Phenprocoumon adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Phenprocoumon
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Product name as reported

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.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From March 2004 to June 2026, FDA received 951 adverse event reports that name Phenprocoumon. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 1,849 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 5 reports in the 12 months to June 2026 and 13 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 5 (under 0.1%) name Phenprocoumon. Reports for patients 75 and over were 48.5% of the reports that name Phenprocoumon and 9.5% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
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.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Phenprocoumon is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

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

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
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.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 2 reports that name Phenprocoumon.
In January to March 2026, FDA received 1.
In April to June 2025, FDA received 2.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 202 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 908 of the 951 reports (95.5%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 202 terms.

Reaction terms in the reports that name Phenprocoumon, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 951 reports
Anaemialow red blood cells	178	18.7%
General physical health deteriorationgeneral decline in health	124	13%
Haematocheziablood in the stool	121	12.7%
Drug interactionan interaction between medicines	111	11.7%
Dyspnoeashortness of breath	76	8%
Haematomaa collection of blood under the skin or in tissue	72	7.6%
Product monitoring error	70	7.4%
Falla fall	69	7.3%
Product prescribing error	69	7.3%
Overdosea dose above the recommended amount	63	6.6%
International normalised ratio increasedblood clotting slower than intended (raised INR)	61	6.4%
Gastrointestinal haemorrhagebleeding in the stomach or bowel	57	6%
Haematuriablood in the urine	45	4.7%
Hypotensionlow blood pressure	45	4.7%
Pallor	45	4.7%
Dizzinesslight-headedness or unsteadiness	41	4.3%
Labelled drug-drug interaction medication error	34	3.6%
Toxicity to various agentspoisoning or toxic effect of one or more substances	34	3.6%
Dehydration	33	3.5%
International normalised ratio abnormal	33	3.5%
Nauseafeeling sick	33	3.5%
Vomitingbeing sick	33	3.5%
Haemoglobin decreasedlow haemoglobin	31	3.3%
Atrial fibrillationan irregular heart rhythm	30	3.2%
Fatiguetiredness	27	2.8%
Acute kidney injurysudden loss of kidney function	26	2.7%
Epistaxisnosebleed	26	2.7%
Astheniaweakness or lack of energy	25	2.6%
Oedema peripheralswelling of the legs, ankles or hands	25	2.6%
Tachycardiafast heart rate	25	2.6%
Melaenablack tarry stools	24	2.5%
Angina pectoris	23	2.4%
Haemoptysiscoughing up blood	23	2.4%
Skin haemorrhage	23	2.4%
Diarrhoealoose or frequent stools	22	2.3%
Respiratory tract haemorrhage	22	2.3%
Stevens-Johnson syndromea severe skin and mucous-membrane reaction	22	2.3%
Depressed level of consciousness	21	2.2%
Pruritusitching	21	2.2%
Circulatory collapsecollapse of the circulation	20	2.1%
Electrolyte imbalance	20	2.1%
Subdural haematoma	20	2.1%
Abdominal painstomach or belly pain	19	2%
Balance disorderproblems with balance	19	2%
Hyponatraemialow blood sodium	19	2%
Off label useused for a purpose or in a way not on the label	19	2%
Coma	18	1.9%
Toxic epidermal necrolysisa severe skin reaction with peeling	18	1.9%
Bradycardiaslow heart rate	17	1.8%
Prothrombin time prolonged	17	1.8%

Download all 202 terms of Phenprocoumon (CSV)

The counts add to more than 951 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. 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.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Phenprocoumon, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	22	22	1	2	21	1	0	5	0
2005	10	9	0	0	5	0	0	5	1
2006	6	6	1	1	3	0	1	0	0
2007	12	12	3	3	11	0	0	4	0
2008	18	18	10	6	15	0	0	3	0
2009	11	11	2	3	11	0	0	2	0
2010	23	23	0	8	18	0	0	4	0
2011	15	15	1	2	11	0	2	6	0
2012	23	23	4	2	13	1	0	11	0
2013	16	16	4	0	5	0	1	11	0
2014	19	19	2	4	13	1	0	10	0
2015	23	23	2	2	21	9	0	7	0
2016	17	17	2	6	15	2	0	11	0
2017	40	40	4	22	27	0	1	20	0
2018	102	102	1	8	95	1	0	19	0
2019	88	87	8	10	74	0	1	27	1
2020	149	148	7	9	139	1	0	54	1
2021	105	105	6	8	98	0	1	30	0
2022	184	184	5	17	155	1	1	93	0
2023	24	24	1	5	22	0	0	10	0
2024	28	28	2	6	24	1	0	16	0
2025	8	8	0	6	7	0	0	8	0
2026	8	8	1	7	7	0	0	6	0

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

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.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Phenprocoumon, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Phenprocoumon, by the year in which FDA received them
Year	Reports
2004	21
2005	12
2006	7
2007	12
2008	19
2009	11
2010	25
2011	19
2012	28
2013	17
2014	13
2015	24
2016	25
2017	39
2018	105
2019	90
2020	152
2021	117
2022	166
2023	16
2024	24
2025	6
2026	3

Reports that name Phenprocoumon, 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.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Phenprocoumon
Age	Reports	Share
Under 2	1	0.1%
2 to 11	1	0.1%
12 to 17	10	1.1%
18 to 44	47	4.9%
45 to 64	112	11.8%
65 to 74	173	18.2%
75 and over	461	48.5%
Age not given	146	15.4%

Sex of the patient in the reports that name Phenprocoumon
Sex	Reports	Share
Female	396	41.6%
Male	452	47.5%
Unknown or not given	103	10.8%

Type of reporter in the reports that name Phenprocoumon
Reporter	Reports	Share
Physician	351	36.9%
Pharmacist	220	23.1%
Other health professional	283	29.8%
Lawyer	0	0%
Consumer or non-health professional	74	7.8%
Not given	23	2.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 1.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Phenprocoumon record
Indication as recorded (MedDRA)	Reports	Share
Atrial fibrillation	82	8.6%
Anticoagulant therapy	57	6%
Thrombosis prophylaxis	14	1.5%
Aortic valve replacement	10	1.1%
Suicide attempt	5	0.5%
Peripheral arterial occlusive disease	3	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 951 reports.

Drugs in the same reports

Other drugs that the reports of Phenprocoumon name, in any role, in order of name
Drug	Reports that name the two
Allopurinol	160
Aspirin	125
Atorvastatin	140
Clopidogrel	136
Metoprolol	175
Pantoprazole	124
Ramipril	220
Simvastatin	173
Torasemid	110
Torsemide	129

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

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.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for PhenprocoumonThe labels (prescribing information) that have this name, at the National Library of Medicine.
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. Phenprocoumon: adverse event reports that FDA received. https://reportedreactions.com/drug/phenprocoumon/ 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.

A report is in the count when it names Phenprocoumon as a suspect or interacting product. The 1,849 reports that name it only as a concomitant medicine are not in the count. 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

Do these reports show that Phenprocoumon was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
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.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Phenprocoumon?

No. It is a count of what people reported to FDA: 951 reports from March 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (36.9%), other health professional (29.8%) and pharmacist (23.1%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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