Diflucan (fluconazole) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Fluconazole
Class: Azole antifungal
Also reported as: Diflucan Capsule

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 2026, FDA received 3,147 adverse event reports that name Diflucan. In these reports the drug is a suspect or interacting product.

In the same period, 10,625 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 65 reports in the 12 months to June 2026 and 73 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, 65 (under 0.1%) name Diflucan. Reports from consumers or other non-health professionals were 32% of the reports that name Diflucan and 45.8% 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 Diflucan 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 14 reports that name Diflucan.
In January to March 2026, FDA received 23.
In April to June 2025, FDA received 18.

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 358 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 3,147 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 358 terms.

Reaction terms in the reports that name Diflucan, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,147 reports
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	389	12.4%
Drug ineffectivethe medicine did not work as expected	277	8.8%
Drug interactionan interaction between medicines	267	8.5%
Nauseafeeling sick	226	7.2%
Pyrexiafever	200	6.4%
Painpain, site not specified	192	6.1%
Headachehead pain	181	5.8%
Erythemaskin redness	174	5.5%
Off label useused for a purpose or in a way not on the label	174	5.5%
Rashskin rash	169	5.4%
Anaemialow red blood cells	148	4.7%
Malaisegeneral feeling of being unwell	137	4.4%
Oral candidiasisoral thrush	136	4.3%
Abdominal painstomach or belly pain	135	4.3%
Constipation	132	4.2%
Fungal infectiona fungal infection	124	3.9%
Weight decreasedweight loss	115	3.7%
Female genital tract fistula	107	3.4%
Rectal haemorrhage	107	3.4%
Diarrhoealoose or frequent stools	106	3.4%
Vaginal discharge	106	3.4%
Colitis ulcerative	105	3.3%
Pruritusitching	105	3.3%
Proctitis	103	3.3%
Radiculopathy	103	3.3%
Vaginal flatulence	103	3.3%
Colitisinflamed bowel	101	3.2%
Haematocheziablood in the stool	100	3.2%
Frequent bowel movements	99	3.1%
Vomitingbeing sick	98	3.1%
Toxic epidermal necrolysisa severe skin reaction with peeling	87	2.8%
Stevens-Johnson syndromea severe skin and mucous-membrane reaction	79	2.5%
Urticariahives	79	2.5%
Therapeutic product effect incomplete	75	2.4%
Dizzinesslight-headedness or unsteadiness	67	2.1%
Chronic sinusitis	66	2.1%
Paraesthesia oral	66	2.1%
Dyspnoeashortness of breath	64	2%
Macular degenerationa disease of the central retina	64	2%
Fatiguetiredness	63	2%
Hypersensitivityan allergic-type reaction	61	1.9%
Astheniaweakness or lack of energy	57	1.8%
Condition aggravatedthe condition being treated got worse	57	1.8%
Dyspepsiaindigestion	56	1.8%
Infusion related reactiona reaction during or soon after an infusion	52	1.7%
Renal impairmentreduced kidney function	51	1.6%
Alanine aminotransferase increasedraised liver enzyme (ALT)	45	1.4%
Procedural painpain from a procedure	42	1.3%
Sepsisa severe body-wide response to infection	42	1.3%
Alopeciahair loss	40	1.3%

Download all 358 terms of Diflucan (CSV)

The counts add to more than 3,147 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 Fluconazole with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Fluconazole	Generic name	17,175
Diflucan (this page)	Brand name	3,147

Sum of the separately reported names: 20,322. 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 Diflucan, 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	147	138	31	24	60	6	1	83	9
2005	139	135	18	13	56	10	1	80	4
2006	109	101	11	12	40	3	0	60	8
2007	84	74	9	6	21	2	1	54	10
2008	135	102	32	10	39	4	1	55	33
2009	104	86	12	6	34	1	0	55	18
2010	139	99	29	6	26	5	0	55	40
2011	120	88	14	7	26	2	4	60	32
2012	96	61	7	6	25	4	1	43	35
2013	158	88	14	12	36	3	2	48	70
2014	180	103	7	10	54	4	0	45	77
2015	154	83	11	7	50	1	3	37	71
2016	185	97	6	7	46	3	2	65	88
2017	158	89	8	6	29	3	4	67	69
2018	186	111	14	13	42	3	0	79	75
2019	202	118	25	20	53	7	0	75	84
2020	149	108	5	16	44	3	1	88	41
2021	132	93	6	4	25	1	1	77	39
2022	154	106	5	2	35	4	0	90	48
2023	142	107	12	10	60	2	1	85	35
2024	134	98	8	10	63	0	0	83	36
2025	85	67	4	3	39	7	1	51	18
2026	55	46	14	10	17	1	1	34	9

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 Diflucan, 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 Diflucan, by the year in which FDA received them
Year	Reports
2004	138
2005	142
2006	108
2007	85
2008	99
2009	92
2010	199
2011	126
2012	120
2013	159
2014	177
2015	162
2016	192
2017	160
2018	190
2019	188
2020	156
2021	150
2022	147
2023	154
2024	103
2025	62
2026	37

Reports that name Diflucan, 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 Diflucan
Age	Reports	Share
Under 2	58	1.8%
2 to 11	37	1.2%
12 to 17	19	0.6%
18 to 44	461	14.6%
45 to 64	684	21.7%
65 to 74	464	14.7%
75 and over	384	12.2%
Age not given	1,040	33%

Sex of the patient in the reports that name Diflucan
Sex	Reports	Share
Female	1,898	60.3%
Male	938	29.8%
Unknown or not given	311	9.9%

Type of reporter in the reports that name Diflucan
Reporter	Reports	Share
Physician	994	31.6%
Pharmacist	295	9.4%
Other health professional	666	21.2%
Lawyer	7	0.2%
Consumer or non-health professional	1,007	32%
Not given	178	5.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 48.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Diflucan record
Indication as recorded (MedDRA)	Reports	Share
Fungal infection	443	14.1%
Oral candidiasis	119	3.8%
Candida infection	107	3.4%
Candidiasis	77	2.4%
Ill-defined disorder	65	2.1%
Infection	60	1.9%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,147 reports.

Drugs in the same reports

Other drugs that the reports of Diflucan name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	137
Aspirin	127
Bactrim	210
Dilaudid	108
Fentanyl	136
Humira	104
Lasix	130
Metronidazole	142
Prednisone	113
Vancomycin	110

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

Fluconazole same ingredient
Cresemba same class
Clotrimazole same class
Isavuconazonium sulfate (kyo) same class
Itraconazole same class
Dificid next in the A to Z list
Difluprednate next in the A to Z list
Diffu K next in the A to Z list
Digitoxin next in the A to Z list
Differin next in the A to Z list
Digoxin next in the A to Z list
Dietary Supplement Herbals next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for DiflucanThe 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. Diflucan: adverse event reports that FDA received. https://reportedreactions.com/drug/diflucan/ 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 Diflucan as a suspect or interacting product. The 10,625 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 Diflucan 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 Diflucan?

No. It is a count of what people reported to FDA: 3,147 reports from January 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?

Consumer or non-health professional (32%), physician (31.6%) and other health professional (21.2%). 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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