Oral candidiasis adverse event reports that record this term

Kind of term: MedDRA preferred term
Plain meaning: oral thrush

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 January 2004 to June 2026, FDA received 12,772 adverse event reports that record the MedDRA preferred term Oral candidiasis. In plain words, the term means: oral thrush. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 984 reports in the 12 months to June 2026 and 894 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.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Plain meaning

Oral thrush. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 102 drug pages with 100 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

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.

Drugs that the reports with the term Oral candidiasis name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetaminophen		265
Adalimumab	Tumor necrosis factor blocker	118
Advair Diskus	Corticosteroid	137
Advair Diskus 100/50		169
Advair Hfa	Corticosteroid	212
Alprazolam	Benzodiazepine	210
Amoxicillin	Penicillin-class antibacterial	222
Aspirin	Nonsteroidal anti-inflammatory drug	175
Atorvastatin calcium	HMG-CoA reductase inhibitor	159
Azithromycin	Macrolide antimicrobial	180
Bactrim	Dihydrofolate reductase inhibitor antibacterial	158
Benzydamine		100
Betamethasone valerate	Corticosteroid	163
Biaxin		146
Bimekizumab		215
Bimzelx		472
Bisacodyl		177
Breo Ellipta	Corticosteroid	198
Budesonide	Corticosteroid	179
Calcium carbonate	Blood coagulation factor	153
Carboplatin	Platinum-based drug	175
Carboxymethylcellulose sodium		114
Cetirizine	Histamine-1 receptor antagonist	110
Ciprofloxacin	Fluoroquinolone antibacterial	143
Ciprofloxacin hydrochloride	Fluoroquinolone antibacterial	128
Cisplatin	Platinum-based drug	148
Clarithromycin	Macrolide antimicrobial	246
Clotrimazole	Azole antifungal	168
Cosentyx	Interleukin-17A antagonist	506
Cyclophosphamide	Alkylating drug	262
Desonide	Corticosteroid	142
Dexamethasone	Corticosteroid	266
Diflucan	Azole antifungal	136
Dilaudid	Opioid agonist	142
Diphenhydramine	Histamine-1 receptor antagonist	141
Docetaxel	Microtubule inhibitor	128
Dupixent	Interleukin-4 receptor alpha antagonist	112
Enbrel	Tumor necrosis factor blocker	309
Entyvio	Integrin receptor antagonist	166
Ergocalciferol	Provitamin D2 compound	165
Ertapenem sodium	Penem antibacterial	119
Fentanyl	Opioid agonist	128
Flovent	Corticosteroid	227
Fluconazole	Azole antifungal	242
Fluorouracil	Nucleoside metabolic inhibitor	117
Fluticasone furoate	Corticosteroid	116
Fluticasone propionate	Corticosteroid	104
Glycerin	Non-Standardized chemical allergen	146
Humira		606
Hydrochlorothiazide	Thiazide diuretic	168
Hydrocortisone	Corticosteroid	180
Hydromorphone hydrochloride	Opioid agonist	157
Infliximab	Tumor necrosis factor blocker	149
Isoniazid	Antimycobacterial	100
Loperamide		106
Magnesium oxide	Calculi dissolution agent	118
Magnesium sulfate	Calculi dissolution agent	144
Mesalamine	Aminosalicylate	192
Methotrexate	Folate analog metabolic inhibitor	451
Methylprednisolone	Corticosteroid	138
Methylprednisolone sodium succinate	Corticosteroid	151
Metronidazole	Nitroimidazole antimicrobial	331
Midazolam	Benzodiazepine	124
Morphine sulfate	Opioid agonist	158
Mupirocin		147
Mycophenolate mofetil	Antimetabolite immunosuppressant	147
Nadolol	beta-Adrenergic blocker	177
Nicoderm Cq	Cholinergic nicotinic agonist	149
Nicotinamide	Copper-containing intrauterine device	129
Nicotine	Cholinergic nicotinic agonist	169
Nitroglycerin	Nitrate vasodilator	151
Orencia	Selective T cell costimulation modulator	121
Oxybutynin chloride	Cholinergic muscarinic antagonist	107
Pantoprazole	Proton pump inhibitor	158
Potassium chloride	Osmotic laxative	173
Prednisolone	Corticosteroid	272
Prednisone	Corticosteroid	677
Pregabalin		152
Refresh Tears		134
Remicade	Tumor necrosis factor blocker	268
Revlimid	Thalidomide analog	140
Ribavirin	Nucleoside analog antiviral	104
Rituximab	CD20-directed cytolytic antibody	271
Simvastatin	HMG-CoA reductase inhibitor	123
Sodium bicarbonate	Osmotic laxative	123
Sodium bicarbonate, sodium chloride	Osmotic laxative	130
Sodium chloride	Osmotic laxative	130
Sucralfate		149
Sulfamethoxazole, trimethoprim	Dihydrofolate reductase inhibitor antibacterial	113
Symbicort	Corticosteroid	251
Tacrolimus	Calcineurin inhibitor immunosuppressant	144
Taltz	Interleukin-17A antagonist	146
Tiotropium bromide	Anticholinergic	185
Trelegy Ellipta	Anticholinergic	192
Triamcinolone acetonide	Corticosteroid	152
Ubidecarenone		102
Vedolizumab	Integrin receptor antagonist	109
Vincristine		113
Xantofyl Palmitate		116
Zeaxanthin		106
Zinc oxide		139
Zopiclone		147

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 28 pharmacologic classes with 250 or more reports that record this term. The rows are in order of name.

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.

Pharmacologic classes of the drugs that the reports with the term Oral candidiasis name, in order of name
Class	Reports with this term
Alkylating drug	375
Aminosalicylate	343
Anticholinergic	665
Azole antifungal	575
Benzodiazepine	446
Calcineurin inhibitor immunosuppressant	257
Calculi dissolution agent	347
CD20-directed cytolytic antibody	471
Cholinergic nicotinic agonist	478
Corticosteroid	4,150
Dihydrofolate reductase inhibitor antibacterial	403
Fluoroquinolone antibacterial	357
Folate analog metabolic inhibitor	608
Histamine-1 receptor antagonist	478
HMG-CoA reductase inhibitor	326
Integrin receptor antagonist	344
Interleukin-17A antagonist	673
Janus kinase inhibitor	255
Kinase inhibitor	461
Macrolide antimicrobial	493
Nitroimidazole antimicrobial	386
Nonsteroidal anti-inflammatory drug	388
Nucleoside metabolic inhibitor	335
Opioid agonist	956
Osmotic laxative	633
Platinum-based drug	407
Proton pump inhibitor	380
Tumor necrosis factor blocker	1,142

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Oral candidiasis, 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.

Patients in these reports

Age of the patient in the reports that record Oral candidiasis
Age	Reports	Share
Under 2	97	0.8%
2 to 11	110	0.9%
12 to 17	104	0.8%
18 to 44	1,722	13.5%
45 to 64	3,259	25.5%
65 to 74	1,950	15.3%
75 and over	1,300	10.2%
Age not given	4,230	33.1%

Sex of the patient in the reports that record Oral candidiasis
Sex	Reports	Share
Female	7,518	58.9%
Male	3,692	28.9%
Unknown or not given	1,562	12.2%

Age and sex are as the report gives them. 51.6% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

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. Oral candidiasis: adverse event reports that record this term. https://reportedreactions.com/reaction/oral-candidiasis/ 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.

The count has the reports with each spelling of one MedDRA preferred term. 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

What does Oral candidiasis mean in an adverse event report?

In plain words: oral thrush. It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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