Phytonadione adverse event reports that FDA received

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

Name type: Generic name

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 February 2004 to June 2026, FDA received 1,132 adverse event reports that name Phytonadione. In these reports the drug is a suspect or interacting product.

In the same period, 6,541 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 116 reports in the 12 months to June 2026 and 88 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Phytonadione 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 35 reports that name Phytonadione.
In January to March 2026, FDA received 26.
In April to June 2025, FDA received 29.

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 184 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 1,083 of the 1,132 reports (95.7%).

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 184 terms.

Reaction terms in the reports that name Phytonadione, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,132 reports
Off label useused for a purpose or in a way not on the label	287	25.4%
Abdominal distensiona bloated abdomen	261	23.1%
Sepsisa severe body-wide response to infection	261	23.1%
Hyponatraemialow blood sodium	259	22.9%
Multiple organ dysfunction syndromeseveral organs failing	258	22.8%
General physical health deteriorationgeneral decline in health	255	22.5%
Stress	246	21.7%
Vomitingbeing sick	242	21.4%
Abdominal painstomach or belly pain	241	21.3%
Ascitesfluid in the abdomen	236	20.8%
Appendicitis	235	20.8%
Appendicolith	233	20.6%
Cardiogenic shockshock from the heart failing to pump	231	20.4%
Nauseafeeling sick	229	20.2%
Constipation	228	20.1%
Drug ineffectivethe medicine did not work as expected	220	19.4%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	218	19.3%
Condition aggravatedthe condition being treated got worse	200	17.7%
Somnolencedrowsiness	181	16%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	176	15.5%
Dry mouth	157	13.9%
Anaemialow red blood cells	156	13.8%
Blood phosphorus increased	156	13.8%
Myasthenia gravis	151	13.3%
Incorrect route of product administrationthe product was given by the wrong route	150	13.3%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	147	13%
Pulmonary embolisma blood clot in the lung	145	12.8%
Product use in unapproved indicationused for a purpose not on the label	144	12.7%
Dyspnoeashortness of breath	140	12.4%
Intentional product misusedeliberate use not as intended	140	12.4%
Diabetes mellitusdiabetes	139	12.3%
Thrombosis	139	12.3%
Neuralgia	138	12.2%
Bacterial infectiona bacterial infection	133	11.7%
Hypophosphataemia	133	11.7%
Drug intolerancethe medicine was not tolerated	132	11.7%
Sleep disordera sleep problem	132	11.7%
Hyperphosphataemia	131	11.6%
Swelling	131	11.6%
Blood cholesterol increasedraised cholesterol	125	11%
Blood uric acid increasedraised uric acid	123	10.9%
Sleep disorder therapy	114	10.1%
Activated partial thromboplastin time prolonged	108	9.5%
Analgesic therapy	108	9.5%
Deaththe patient died; cause not stated by this term	106	9.4%
Iron deficiency	100	8.8%
Gout	99	8.7%
End stage renal diseasekidney failure needing dialysis or transplant	97	8.6%
Drug therapy	96	8.5%
Ulcer	96	8.5%

Download all 184 terms of Phytonadione (CSV)

The counts add to more than 1,132 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.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Phytonadione with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Phytonadione (this page)	Generic name	1,132
Vitamin K1	Brand name	384

Sum of the separately reported names: 1,516. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

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

Outcomes in the reports that name Phytonadione, 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	6	4	0	1	1	0	0	2	2
2005	5	5	2	1	2	0	0	1	0
2006	8	6	0	0	4	1	0	1	2
2007	12	9	1	2	1	0	0	7	3
2008	8	7	1	2	4	1	0	1	1
2009	10	8	2	2	3	0	0	3	2
2010	8	8	1	5	6	0	0	5	0
2011	17	15	0	4	5	0	0	6	2
2012	4	3	1	0	1	0	0	1	1
2013	23	19	4	4	6	1	0	10	4
2014	36	33	5	4	10	1	4	16	3
2015	35	28	4	4	10	1	0	18	7
2016	43	41	6	2	7	1	0	31	2
2017	38	36	5	6	16	1	1	20	2
2018	49	46	10	5	21	0	0	26	3
2019	51	40	6	5	25	2	0	21	11
2020	49	42	6	11	25	5	0	25	7
2021	111	107	44	9	36	3	1	81	4
2022	142	136	70	16	43	31	3	99	6
2023	142	135	89	57	94	62	2	104	7
2024	104	93	45	38	54	33	9	77	11
2025	128	120	69	66	86	55	36	98	8
2026	103	101	79	58	78	66	50	81	2

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 Phytonadione, 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 Phytonadione, by the year in which FDA received them
Year	Reports
2004	6
2005	5
2006	8
2007	18
2008	7
2009	11
2010	8
2011	17
2012	8
2013	20
2014	40
2015	40
2016	42
2017	42
2018	44
2019	55
2020	71
2021	175
2022	115
2023	144
2024	94
2025	101
2026	61

Reports that name Phytonadione, 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 Phytonadione
Age	Reports	Share
Under 2	61	5.4%
2 to 11	13	1.1%
12 to 17	13	1.1%
18 to 44	118	10.4%
45 to 64	213	18.8%
65 to 74	97	8.6%
75 and over	394	34.8%
Age not given	223	19.7%

Sex of the patient in the reports that name Phytonadione
Sex	Reports	Share
Female	356	31.4%
Male	654	57.8%
Unknown or not given	122	10.8%

Type of reporter in the reports that name Phytonadione
Reporter	Reports	Share
Physician	190	16.8%
Pharmacist	176	15.5%
Other health professional	627	55.4%
Lawyer	1	0.1%
Consumer or non-health professional	104	9.2%
Not given	34	3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 34.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Phytonadione record
Indication as recorded (MedDRA)	Reports	Share
Vitamin supplementation	264	23.3%
Coagulopathy	38	3.4%
International normalised ratio increased	31	2.7%
Off label use	24	2.1%
Ill-defined disorder	17	1.5%
Parenteral nutrition	14	1.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,132 reports.

Drugs in the same reports

Other drugs that the reports of Phytonadione name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	384
Allopurinol	290
Dextrose	298
Gabapentin	282
Ipratropium bromide	314
Lansoprazole	325
Metronidazole	321
Ondansetron	313
Potassium chloride	327
Simvastatin	290

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.

Pages near this one

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for PhytonadioneThe 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. Phytonadione: adverse event reports that FDA received. https://reportedreactions.com/drug/phytonadione/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Phytonadione as a suspect or interacting product. The 6,541 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 Phytonadione 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 Phytonadione?

No. It is a count of what people reported to FDA: 1,132 reports from February 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?

Other health professional (55.4%), physician (16.8%) and pharmacist (15.5%). 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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