Triflucan adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Triflucan
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 January 2004 to June 2021, FDA received 940 adverse event reports that name Triflucan. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 686 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received no report that names Triflucan in the five years to June 2026. The latest report was received in June 2021.

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 Triflucan 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.

FDA received no report that names Triflucan in April to June 2026, in January to March 2026 or in April to June 2025.

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 109 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 all 940 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 109 terms.

Reaction terms in the reports that name Triflucan, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 940 reports
Drug interactionan interaction between medicines	85	9%
Thrombocytopenialow platelets	70	7.4%
Cholestasis	50	5.3%
Neutropenialow neutrophils, a type of white blood cell	49	5.2%
Anaemialow red blood cells	46	4.9%
Pyrexiafever	42	4.5%
Hepatocellular injury	40	4.3%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	38	4%
International normalised ratio increasedblood clotting slower than intended (raised INR)	36	3.8%
Rash maculo-papulara rash of flat and raised spots	33	3.5%
Toxic skin eruption	30	3.2%
Leukopenialow white blood cells	29	3.1%
Pancytopenialow counts of all blood cells	29	3.1%
Rashskin rash	28	3%
Agranulocytosis	25	2.7%
Toxic epidermal necrolysisa severe skin reaction with peeling	25	2.7%
Hepatitis	23	2.4%
Gamma-glutamyltransferase increased	22	2.3%
Dermatitis bullous	21	2.2%
Stevens-Johnson syndromea severe skin and mucous-membrane reaction	21	2.2%
Diarrhoealoose or frequent stools	20	2.1%
Pruritusitching	20	2.1%
Renal failure acute	20	2.1%
General physical health deteriorationgeneral decline in health	18	1.9%
Off label useused for a purpose or in a way not on the label	17	1.8%
Purpura	17	1.8%
Septic shockshock arising from infection	17	1.8%
Blood alkaline phosphatase increased	16	1.7%
Cytolytic hepatitis	16	1.7%
Encephalopathy	16	1.7%
Renal failurekidney failure	16	1.7%
Vomitingbeing sick	16	1.7%
Alanine aminotransferase increasedraised liver enzyme (ALT)	15	1.6%
Acute kidney injurysudden loss of kidney function	14	1.5%
Aspartate aminotransferase increasedraised liver enzyme (AST)	13	1.4%
Astheniaweakness or lack of energy	13	1.4%
Dyspnoeashortness of breath	13	1.4%
Eosinophilia	13	1.4%
Myocarditisinflammation of the heart muscle	13	1.4%
Skin exfoliationpeeling skin	13	1.4%
Atrial fibrillationan irregular heart rhythm	12	1.3%
Jaundice cholestatic	12	1.3%
Rash erythematousa red rash	12	1.3%
Cardio-respiratory arrestthe heart and breathing stopped	11	1.2%
Condition aggravatedthe condition being treated got worse	11	1.2%
Overdosea dose above the recommended amount	11	1.2%
Confusional stateconfusion	10	1.1%
Haematomaa collection of blood under the skin or in tissue	10	1.1%
Jaundiceyellowing of the skin or eyes	10	1.1%
Paraesthesiatingling or pins and needles	10	1.1%

Download all 109 terms of Triflucan (CSV)

The counts add to more than 940 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 Triflucan, 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	21	21	5	2	19	0	0	2	0
2005	33	33	8	3	25	1	1	2	0
2006	30	30	7	1	23	0	0	4	0
2007	86	86	18	18	61	3	0	14	0
2008	80	78	14	17	58	1	0	11	2
2009	81	81	8	9	67	0	0	6	0
2010	59	59	8	3	48	0	1	9	0
2011	36	36	2	7	27	0	0	9	0
2012	22	22	2	2	16	0	0	4	0
2013	77	77	8	8	64	0	0	13	0
2014	60	60	8	12	43	0	0	13	0
2015	65	65	16	9	41	1	0	22	0
2016	53	53	4	6	37	0	0	24	0
2017	64	64	0	6	48	0	0	23	0
2018	72	72	17	15	36	0	0	30	0
2019	51	51	2	9	37	0	0	24	0
2020	36	36	10	2	23	0	0	17	0
2021	14	14	3	0	14	0	0	4	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 Triflucan, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Triflucan, by the year in which FDA received them
Year	Reports
2004	20
2005	28
2006	37
2007	86
2008	80
2009	81
2010	63
2011	42
2012	33
2013	73
2014	63
2015	64
2016	51
2017	67
2018	73
2019	37
2020	35
2021	7

FDA received no report that names Triflucan in the five years to June 2026. FDA received the latest report in June 2021.

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 Triflucan
Age	Reports	Share
Under 2	19	2%
2 to 11	17	1.8%
12 to 17	14	1.5%
18 to 44	137	14.6%
45 to 64	246	26.2%
65 to 74	130	13.8%
75 and over	196	20.9%
Age not given	181	19.3%

Sex of the patient in the reports that name Triflucan
Sex	Reports	Share
Female	429	45.6%
Male	442	47%
Unknown or not given	69	7.3%

Type of reporter in the reports that name Triflucan
Reporter	Reports	Share
Physician	203	21.6%
Pharmacist	30	3.2%
Other health professional	539	57.3%
Lawyer	0	0%
Consumer or non-health professional	121	12.9%
Not given	47	5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 0.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Triflucan record
Indication as recorded (MedDRA)	Reports	Share
Fungal infection	55	5.9%
Candida infection	39	4.1%
Oral candidiasis	39	4.1%
Oral fungal infection	39	4.1%
Infection	36	3.8%
Candidiasis	29	3.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 940 reports.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for TriflucanThe 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. Triflucan: adverse event reports that FDA received. https://reportedreactions.com/drug/triflucan/ 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 Triflucan as a suspect or interacting product. The 686 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 Triflucan 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 Triflucan?

No. It is a count of what people reported to FDA: 940 reports from January 2004 to June 2021. 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 (57.3%), physician (21.6%) and consumer or non-health professional (12.9%). 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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