Coagulopathy adverse event reports that record this term

Kind of term: MedDRA preferred term

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

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

Reports on file

From January 2004 to June 2026, FDA received 16,325 adverse event reports that record the MedDRA preferred term Coagulopathy. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 749 reports in the 12 months to June 2026 and 710 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 766 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 749 (0.1%) record this term. Reports for male patients were 42.7% of the reports that record this term and 34.6% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 101 drug pages with 50 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Coagulopathy name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetaminophen		887
Acetylsalicylic Acid		198
Amiodarone		71
Amlodipine	Calcium channel blocker	68
Amoxicillin	Penicillin-class antibacterial	107
Apixaban	Factor Xa inhibitor	123
Arava	Antirheumatic agent	52
Aspirin	Nonsteroidal anti-inflammatory drug	519
Atorvastatin		80
Azathioprine	Purine antimetabolite	67
Bevacizumab	Vascular endothelial growth factor inhibitor	64
Budesonide	Corticosteroid	70
Capecitabine	Nucleoside metabolic inhibitor	103
Carboplatin	Platinum-based drug	80
Cefazolin	Cephalosporin antibacterial	70
Ceftriaxone	Cephalosporin antibacterial	52
Ciprofloxacin	Fluoroquinolone antibacterial	73
Cisplatin	Platinum-based drug	78
Clarithromycin	Macrolide antimicrobial	108
Clopidogrel	P2Y12 platelet inhibitor	82
Colchicine	Alkaloid	79
Coumadin		419
Cyclophosphamide	Alkylating drug	310
Cyclosporine	Calcineurin inhibitor immunosuppressant	82
Cytarabine	Nucleoside metabolic inhibitor	238
Dabigatran		102
Daunorubicin		72
Dexamethasone	Corticosteroid	268
Diclofenac	Nonsteroidal anti-inflammatory drug	53
Digoxin	Cardiac glycoside	85
Doxorubicin	Anthracycline topoisomerase inhibitor	114
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	98
Eliquis	Factor Xa inhibitor	159
Enbrel	Tumor necrosis factor blocker	98
Enoxaparin sodium	Low molecular weight heparin	90
Etoposide	Topoisomerase inhibitor	145
Fentanyl	Opioid agonist	82
Fluconazole	Azole antifungal	80
Fluorouracil	Nucleoside metabolic inhibitor	107
Fosamax	Bisphosphonate	70
Furosemide	Loop diuretic	71
Gabapentin	Anti-epileptic agent	64
Heparin		139
Heparin sodium	Anti-coagulant	200
Humira		186
Hydrocortisone	Corticosteroid	65
Ibuprofen	Nonsteroidal anti-inflammatory drug	259
Ifosfamide	Alkylating drug	53
Isoniazid	Antimycobacterial	73
Kymriah	CD19-directed chimeric antigen receptor	64
Lansoprazole	Proton pump inhibitor	74
Levetiracetam		77
Levofloxacin	Fluoroquinolone antibacterial	66
Linezolid	Oxazolidinone antibacterial	50
Lisinopril	Angiotensin converting enzyme inhibitor	68
Lovenox	Low molecular weight heparin	61
Mercaptopurine	Nucleoside metabolic inhibitor	101
Meropenem	Penem antibacterial	71
Metformin	Biguanide	148
Methotrexate	Folate analog metabolic inhibitor	493
Methotrexate sodium	Folate analog metabolic inhibitor	61
Methylprednisolone	Corticosteroid	165
Metoprolol	beta-Adrenergic blocker	77
Metronidazole	Nitroimidazole antimicrobial	77
Midazolam	Benzodiazepine	77
Mycophenolate mofetil	Antimetabolite immunosuppressant	191
Naproxen	Nonsteroidal anti-inflammatory drug	50
Nuvaring	Estrogen	257
Omeprazole	Proton pump inhibitor	61
Oncaspar	Asparagine-specific enzyme	85
Oxaliplatin	Platinum-based drug	85
Oxycodone	Opioid agonist	64
Paclitaxel	Microtubule inhibitor	57
Paracetamol		247
Pegaspargase	Asparagine-specific enzyme	83
Plavix	P2Y12 platelet inhibitor	178
Pradaxa	Direct thrombin inhibitor	1,223
Prednisolone	Corticosteroid	178
Prednisone	Corticosteroid	287
Prograf	Calcineurin inhibitor immunosuppressant	52
Propofol	General anesthetic	102
Quinine sulfate	Antimalarial	50
Revlimid	Thalidomide analog	74
Rifampicin		52
Rifampin	Rifamycin antibacterial	60
Rituximab	CD20-directed cytolytic antibody	149
Rivaroxaban	Factor Xa inhibitor	148
Tacrolimus	Calcineurin inhibitor immunosuppressant	169
Tigecycline	Tetracycline-class antibacterial	113
Tracleer	Endothelin receptor antagonist	50
Tygacil	Tetracycline-class antibacterial	78
Tylenol	Expectorant	63
Valproic acid	Anti-epileptic agent	101
Vancomycin	Glycopeptide antibacterial	74
Vincristine		203
Vincristine sulfate	Vinca alkaloid	185
Vioxx		75
Warfarin	Vitamin K antagonist	415
Warfarin sodium	Vitamin K antagonist	333
Xarelto	Factor Xa inhibitor	976
Zometa		53

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 45 pharmacologic classes with 100 or more reports that record this term. The rows are in order of name.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Coagulopathy name, in order of name
Class	Reports with this term
Alkylating drug	470
Angiotensin converting enzyme inhibitor	102
Anthracycline topoisomerase inhibitor	270
Anti-coagulant	245
Anti-epileptic agent	356
Antimetabolite immunosuppressant	230
Antimycobacterial	110
Asparagine-specific enzyme	170
Atypical antipsychotic	173
Azole antifungal	164
Benzodiazepine	244
beta-Adrenergic blocker	132
Biguanide	211
Bisphosphonate	103
Calcineurin inhibitor immunosuppressant	324
CD20-directed cytolytic antibody	164
Cephalosporin antibacterial	159
Corticosteroid	1,077
Direct thrombin inhibitor	1,270
Endothelin receptor antagonist	118
Estrogen	266
Factor Xa inhibitor	1,448
Fluoroquinolone antibacterial	152
Folate analog metabolic inhibitor	558
General anesthetic	152
HMG-CoA reductase inhibitor	123
Janus kinase inhibitor	132
Kinase inhibitor	406
Low molecular weight heparin	151
Macrolide antimicrobial	144
Nonsteroidal anti-inflammatory drug	1,106
Nucleoside metabolic inhibitor	705
Opioid agonist	338
P2Y12 platelet inhibitor	337
Penicillin-class antibacterial	177
Platinum-based drug	243
Proton pump inhibitor	205
Serotonin reuptake inhibitor	137
Tetracycline-class antibacterial	191
Thalidomide analog	107
Topoisomerase inhibitor	167
Tumor necrosis factor blocker	206
Vascular endothelial growth factor inhibitor	126
Vinca alkaloid	188
Vitamin K antagonist	748

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Coagulopathy, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Coagulopathy
Age	Reports	Share
Under 2	272	1.7%
2 to 11	545	3.3%
12 to 17	561	3.4%
18 to 44	2,621	16.1%
45 to 64	3,423	21%
65 to 74	2,335	14.3%
75 and over	2,768	17%
Age not given	3,800	23.3%

Sex of the patient in the reports that record Coagulopathy
Sex	Reports	Share
Female	8,034	49.2%
Male	6,972	42.7%
Unknown or not given	1,319	8.1%

Age and sex are as the report gives them. 54% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Coagulopathy: adverse event reports that record this term. https://reportedreactions.com/reaction/coagulopathy/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

What does Coagulopathy mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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