Posaconazole adverse event reports that FDA received

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

Name type: Generic name
Class: Azole antifungal
Also reported as: Posaconazole Delayed Release

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 June 2004 to June 2026, FDA received 4,234 adverse event reports that name Posaconazole. In these reports the drug is a suspect or interacting product.

In the same period, 6,711 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 589 reports in the 12 months to June 2026 and 589 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, 589 (under 0.1%) name Posaconazole. Reports from consumers or other non-health professionals were 6.9% of the reports that name Posaconazole 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 Posaconazole 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 159 reports that name Posaconazole.
In January to March 2026, FDA received 148.
In April to June 2025, FDA received 184.

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 509 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 4,229 of the 4,234 reports (99.9%).

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 509 terms.

Reaction terms in the reports that name Posaconazole, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,234 reports
Drug ineffectivethe medicine did not work as expected	779	18.4%
Drug interactionan interaction between medicines	735	17.4%
Product use in unapproved indicationused for a purpose not on the label	348	8.2%
Off label useused for a purpose or in a way not on the label	344	8.1%
Neutropenialow neutrophils, a type of white blood cell	200	4.7%
Condition aggravatedthe condition being treated got worse	198	4.7%
Deaththe patient died; cause not stated by this term	188	4.4%
Febrile neutropeniafever with low white blood cells	166	3.9%
Septic shockshock arising from infection	156	3.7%
Acute kidney injurysudden loss of kidney function	154	3.6%
Aspergillus infection	143	3.4%
Pyrexiafever	138	3.3%
Electrocardiogram QT prolongeda QT prolongation on the ECG	123	2.9%
Drug resistance	122	2.9%
Hypokalaemialow blood potassium	121	2.9%
Pancytopenialow counts of all blood cells	105	2.5%
Hepatic cytolysis	104	2.5%
Toxicity to various agentspoisoning or toxic effect of one or more substances	100	2.4%
Diarrhoealoose or frequent stools	99	2.3%
Disease progressionthe disease advanced	98	2.3%
Mucormycosis	98	2.3%
Fungal infectiona fungal infection	94	2.2%
Pneumonialung infection	91	2.1%
Respiratory failurethe lungs could not supply enough oxygen	90	2.1%
Thrombocytopenialow platelets	87	2.1%
Nauseafeeling sick	86	2%
Drug ineffective for unapproved indication	84	2%
Bronchopulmonary aspergillosis	83	2%
Product use issuea problem in how the product was used	82	1.9%
Infectionan infection, type not specified	80	1.9%
Hepatotoxicityliver injury	73	1.7%
Cholestasis	72	1.7%
Multiple organ dysfunction syndromeseveral organs failing	71	1.7%
Vomitingbeing sick	71	1.7%
Renal failurekidney failure	67	1.6%
Renal impairmentreduced kidney function	67	1.6%
Dyspnoeashortness of breath	65	1.5%
Fatiguetiredness	65	1.5%
Hyperbilirubinaemia	65	1.5%
Hypertensionhigh blood pressure	64	1.5%
Pseudoaldosteronism	64	1.5%
Treatment failurethe treatment did not work	63	1.5%
Drug level increaseda raised blood level of the medicine	62	1.5%
Drug intolerancethe medicine was not tolerated	60	1.4%
Astheniaweakness or lack of energy	58	1.4%
Drug level decreaseda low blood level of the medicine	56	1.3%
Rashskin rash	56	1.3%
Haemorrhagebleeding	55	1.3%
Pneumonia fungal	52	1.2%
Candida infectionthrush, a yeast infection	51	1.2%

Download all 509 terms of Posaconazole (CSV)

The counts add to more than 4,234 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 Posaconazole with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Posaconazole (this page)	Generic name	4,234
Noxafil	Brand name	3,230

Sum of the separately reported names: 7,464. 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 Posaconazole, 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	Other Serious (Important Medical Events)	Not serious
2004	5	5	3	2	4	0	1	0
2005	18	18	6	7	9	1	13	0
2006	30	30	11	13	15	1	12	0
2007	29	28	10	5	18	0	14	1
2008	15	15	6	2	7	0	6	0
2009	40	40	13	3	17	2	17	0
2010	23	23	6	2	7	1	12	0
2011	44	44	16	3	14	1	21	0
2012	64	58	22	11	21	1	35	6
2013	36	33	15	2	13	0	15	3
2014	67	64	37	2	12	4	25	3
2015	60	51	21	6	13	1	30	9
2016	87	82	19	11	47	0	45	5
2017	122	116	40	10	46	1	84	6
2018	258	251	96	16	85	6	207	7
2019	171	158	37	20	53	5	132	13
2020	268	253	63	23	127	6	194	15
2021	347	343	41	17	159	3	266	4
2022	372	351	86	46	171	12	239	21
2023	526	502	119	40	192	17	351	24
2024	643	616	143	88	266	4	451	27
2025	646	522	149	36	224	2	392	124
2026	363	278	52	16	111	0	205	85

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 Posaconazole, 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 Posaconazole, by the year in which FDA received them
Year	Reports
2004	3
2005	18
2006	28
2007	31
2008	15
2009	40
2010	27
2011	47
2012	73
2013	37
2014	67
2015	59
2016	103
2017	181
2018	241
2019	196
2020	279
2021	373
2022	354
2023	580
2024	601
2025	574
2026	307

Reports that name Posaconazole, 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 Posaconazole
Age	Reports	Share
Under 2	36	0.9%
2 to 11	260	6.1%
12 to 17	143	3.4%
18 to 44	874	20.6%
45 to 64	1,269	30%
65 to 74	658	15.5%
75 and over	317	7.5%
Age not given	677	16%

Sex of the patient in the reports that name Posaconazole
Sex	Reports	Share
Female	1,480	35%
Male	2,203	52%
Unknown or not given	551	13%

Type of reporter in the reports that name Posaconazole
Reporter	Reports	Share
Physician	1,408	33.3%
Pharmacist	337	8%
Other health professional	2,133	50.4%
Lawyer	0	0%
Consumer or non-health professional	291	6.9%
Not given	65	1.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 33.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Posaconazole record
Indication as recorded (MedDRA)	Reports	Share
Antifungal prophylaxis	747	17.6%
Prophylaxis	361	8.5%
Fungal infection	217	5.1%
Mucormycosis	194	4.6%
Aspergillus infection	162	3.8%
Bronchopulmonary aspergillosis	149	3.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,234 reports.

Drugs in the same reports

Other drugs that the reports of Posaconazole name, in any role, in order of name
Drug	Reports that name the two
Acyclovir	403
Amphotericin b	819
Cyclosporine	255
Cytarabine	449
Meropenem	277
Mycophenolate mofetil	315
Prednisone	410
Tacrolimus	578
Venetoclax	318
Voriconazole	803

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

Noxafil same ingredient
Sporanox same class
Nizoral same class
Terconazole same class
Miconazole nitrate same class
Tioconazole same class
Ponvory next in the A to Z list
Potassium next in the A to Z list
Ponatinib next in the A to Z list
Potassium chloride next in the A to Z list
Pomalyst next in the A to Z list
Potassium citrate 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 PosaconazoleThe 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. Posaconazole: adverse event reports that FDA received. https://reportedreactions.com/drug/posaconazole/ 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 Posaconazole as a suspect or interacting product. The 6,711 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 Posaconazole 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 Posaconazole?

No. It is a count of what people reported to FDA: 4,234 reports from June 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 (50.4%), physician (33.3%) and pharmacist (8%). 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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