Oral mucosal blistering adverse event reports that record this term

Kind of term: MedDRA preferred term

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 6,294 adverse event reports that record the MedDRA preferred term Oral mucosal blistering. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 336 reports in the 12 months to June 2026 and 302 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.

Data version

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

Drugs in these reports

The table has the 123 drug pages with 10 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 mucosal blistering name as a suspect product, in order of name
Drug	Class	Reports with this term
Abreva	Non-Standardized chemical allergen	12
Actemra	Interleukin-6 receptor antagonist	27
Advair Diskus	Corticosteroid	21
Advair Diskus 100/50		20
Afinitor	Kinase inhibitor	109
Aimovig		12
Alendronic Acid		11
Amoxicillin	Penicillin-class antibacterial	25
Anoro Ellipta	Anticholinergic	14
Atorvastatin		19
Aubagio	Pyrimidine synthesis inhibitor	16
Avonex	Interferon beta	12
Azathioprine	Purine antimetabolite	12
Bextra		23
Bimzelx		16
Bisoprolol	beta-Adrenergic blocker	10
Breo Ellipta	Corticosteroid	34
Buprenorphine	Partial opioid agonist	19
Buprenorphine and naloxone	Opioid antagonist	20
Buprenorphine Naloxone		10
Bupropion hydrochloride	Aminoketone	11
Cabometyx	Kinase inhibitor	167
Capecitabine	Nucleoside metabolic inhibitor	27
Cefalexin		10
Chantix	Partial cholinergic nicotinic agonist	46
Cimzia	Tumor necrosis factor blocker	10
Ciprofloxacin	Fluoroquinolone antibacterial	19
Clarithromycin	Macrolide antimicrobial	52
Cometriq	Kinase inhibitor	16
Commit		19
Copegus		13
Cosentyx	Interleukin-17A antagonist	66
Cymbalta	Serotonin and norepinephrine reuptake inhibitor	28
Doxycycline	Tetracycline-class drug	16
Dupixent	Interleukin-4 receptor alpha antagonist	136
Eliquis	Factor Xa inhibitor	12
Enbrel	Tumor necrosis factor blocker	128
Erlotinib	Kinase inhibitor	10
Esbriet	Pyridone	12
Everolimus	Kinase inhibitor	13
Fluconazole	Azole antifungal	18
Forteo	Parathyroid hormone analog	17
Gabapentin	Anti-epileptic agent	22
Gilenya	Sphingosine 1-phosphate receptor modulator	19
Gilotrif	Kinase inhibitor	16
Gleevec	Kinase inhibitor	11
Human immunoglobulin g	Human immunoglobulin G	13
Humira		191
Ibrance	Kinase inhibitor	155
Ibuprofen	Nonsteroidal anti-inflammatory drug	45
Imbruvica	Kinase inhibitor	68
Incivek		46
Inlyta	Kinase inhibitor	43
Jakafi	Janus kinase inhibitor	27
Kevzara	Interleukin-6 receptor antagonist	23
Keytruda	Programmed death Receptor-1 blocking antibody	20
Kisqali	Kinase inhibitor	34
Lamictal	Anti-epileptic agent	65
Lamotrigine	Anti-epileptic agent	66
Lenvima	Kinase inhibitor	35
Letrozole	Aromatase inhibitor	14
Lisinopril	Angiotensin converting enzyme inhibitor	17
Losartan	Angiotensin 2 receptor blocker	10
Lyrica		42
Methotrexate	Folate analog metabolic inhibitor	102
Methotrexate sodium	Folate analog metabolic inhibitor	43
Metronidazole	Nitroimidazole antimicrobial	18
Montelukast	Leukotriene receptor antagonist	10
Mycophenolate mofetil	Antimetabolite immunosuppressant	20
Naproxen	Nonsteroidal anti-inflammatory drug	22
Nexavar	Kinase inhibitor	42
Nexium	Proton pump inhibitor	19
Nicorette	Cholinergic nicotinic agonist	17
Nicotine polacrilex	Cholinergic nicotinic agonist	31
Niraparib	Poly(ADP-Ribose) polymerase inhibitor	18
Ocrevus	CD20-directed cytolytic antibody	21
Omeprazole	Proton pump inhibitor	34
Opdivo	Programmed death Receptor-1 blocking antibody	25
Orencia	Selective T cell costimulation modulator	32
Oxaliplatin	Platinum-based drug	14
Paxlovid		36
Pegasys	Interferon alpha	95
Pegintron		10
Piqray		25
Pomalyst	Thalidomide analog	24
Prednisone	Corticosteroid	52
Prolia	RANK ligand inhibitor	45
Ramipril	Angiotensin converting enzyme inhibitor	15
Remicade	Tumor necrosis factor blocker	11
Repatha	PCSK9 inhibitor	34
Revlimid	Thalidomide analog	101
Ribasphere		15
Ribavirin	Nucleoside analog antiviral	90
Rinvoq	Janus kinase inhibitor	26
Rituxan	CD20-directed cytolytic antibody	22
Rituximab	CD20-directed cytolytic antibody	40
Rosuvastatin	HMG-CoA reductase inhibitor	14
Sandostatin LAR Depot		12
Saphris	Atypical antipsychotic	24
Sertraline	Serotonin reuptake inhibitor	18
Simvastatin	HMG-CoA reductase inhibitor	14
Sovaldi	Hepatitis C virus nucleotide analog NS5B polymerase inhibitor	16
Stelara	Interleukin-12 antagonist	10
Stivarga	Kinase inhibitor	24
Suboxone	Opioid antagonist	94
Sutent	Kinase inhibitor	146
Symbicort	Corticosteroid	27
Tamsulosin		10
Tarceva		12
Tecfidera		13
Telaprevir		18
Tiotropium bromide	Anticholinergic	24
Trelegy Ellipta	Anticholinergic	22
Tykerb	Kinase inhibitor	12
Tylenol	Expectorant	11
Tysabri	Integrin receptor antagonist	13
Votrient	Kinase inhibitor	10
Vx-950		22
Xarelto	Factor Xa inhibitor	13
Xeljanz	Janus kinase inhibitor	94
Xeloda	Nucleoside metabolic inhibitor	34
Xolair	Anti-IgE	11
Zejula	Poly(ADP-Ribose) polymerase inhibitor	22

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 38 pharmacologic classes with 25 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 mucosal blistering name, in order of name
Class	Reports with this term
Angiotensin 2 receptor blocker	43
Angiotensin converting enzyme inhibitor	34
Anti-epileptic agent	162
Anticholinergic	66
Aromatase inhibitor	32
Atypical antipsychotic	48
CD20-directed cytolytic antibody	91
Cholinergic nicotinic agonist	58
Corticosteroid	180
Factor Xa inhibitor	25
Fluoroquinolone antibacterial	27
Folate analog metabolic inhibitor	155
HMG-CoA reductase inhibitor	37
Human immunoglobulin G	30
Interferon alpha	95
Interleukin-17A antagonist	73
Interleukin-4 receptor alpha antagonist	139
Interleukin-6 receptor antagonist	52
Janus kinase inhibitor	147
Kinase inhibitor	983
Macrolide antimicrobial	52
Nonsteroidal anti-inflammatory drug	103
Nucleoside analog antiviral	90
Nucleoside metabolic inhibitor	73
Opioid antagonist	126
Partial cholinergic nicotinic agonist	46
Partial opioid agonist	27
PCSK9 inhibitor	39
Penicillin-class antibacterial	29
Poly(ADP-Ribose) polymerase inhibitor	50
Programmed death Receptor-1 blocking antibody	53
Proton pump inhibitor	59
RANK ligand inhibitor	47
Selective T cell costimulation modulator	36
Serotonin and norepinephrine reuptake inhibitor	39
Serotonin reuptake inhibitor	26
Thalidomide analog	127
Tumor necrosis factor blocker	171

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

Reports by month

Reports that record Oral mucosal blistering, 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 mucosal blistering
Age	Reports	Share
Under 2	15	0.2%
2 to 11	73	1.2%
12 to 17	62	1%
18 to 44	749	11.9%
45 to 64	1,730	27.5%
65 to 74	963	15.3%
75 and over	588	9.3%
Age not given	2,114	33.6%

Sex of the patient in the reports that record Oral mucosal blistering
Sex	Reports	Share
Female	4,301	68.3%
Male	1,473	23.4%
Unknown or not given	520	8.3%

Age and sex are as the report gives them. 73.4% 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 mucosal blistering: adverse event reports that record this term. https://reportedreactions.com/reaction/oral-mucosal-blistering/ 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 mucosal blistering mean in an adverse event report?

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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