Laryngeal oedema adverse event reports that record this term

Kind of term: MedDRA preferred term
Plain meaning: swelling of the voice box

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 6,050 adverse event reports that record the MedDRA preferred term Laryngeal oedema. In plain words, the term means: swelling of the voice box. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 330 reports in the 12 months to June 2026 and 289 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 1,189 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 330 (under 0.1%) record this term. Reports for patients aged 45 to 64 were 28.6% of the reports that record this term and 20% of all drug reports.

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

Swelling of the voice box. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 100 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 Laryngeal oedema name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetaminophen		54
Acetylsalicylic Acid		17
Actemra	Interleukin-6 receptor antagonist	22
Afinitor	Kinase inhibitor	10
Altace		16
Alteplase		25
Amlodipine	Calcium channel blocker	16
Amoxicillin	Penicillin-class antibacterial	82
Amoxicillin Clavulanic Acid		18
Amoxicilline		15
Aspirin	Nonsteroidal anti-inflammatory drug	53
Atenolol	beta-Adrenergic blocker	20
Atorvastatin		18
Atorvastatin calcium	HMG-CoA reductase inhibitor	18
Augmentin '125		23
Benlysta	B lymphocyte stimulator-specific inhibitor	11
Berinert		10
Carboplatin	Platinum-based drug	62
Celebrex	Nonsteroidal anti-inflammatory drug	13
Cinryze	Human C1 esterase inhibitor	77
Ciprofloxacin	Fluoroquinolone antibacterial	12
Cisplatin	Platinum-based drug	44
Clarithromycin	Macrolide antimicrobial	11
Clopidogrel	P2Y12 platelet inhibitor	15
Cosentyx	Interleukin-17A antagonist	18
Cyclophosphamide	Alkylating drug	31
Cyclosporine	Calcineurin inhibitor immunosuppressant	16
Darzalex	CD38-directed cytolytic antibody	25
Dexamethasone	Corticosteroid	31
Diclofenac	Nonsteroidal anti-inflammatory drug	29
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	28
Diovan	Angiotensin 2 receptor blocker	25
Diprivan	General anesthetic	12
Docetaxel	Microtubule inhibitor	53
Dotarem	Gadolinium-based contrast agent	33
Dupixent	Interleukin-4 receptor alpha antagonist	10
Eloxatin		17
Enalapril	Angiotensin converting enzyme inhibitor	11
Enalapril maleate	Angiotensin converting enzyme inhibitor	12
Enbrel	Tumor necrosis factor blocker	35
Entresto	Angiotensin 2 receptor blocker	24
Erbitux	Epidermal growth factor receptor antagonist	33
Ferinject		29
Firazyr	Bradykinin B2 receptor antagonist	98
Fluorescite		14
Fluorouracil	Nucleoside metabolic inhibitor	54
Furosemide	Loop diuretic	17
Humira		88
Ibuprofen	Nonsteroidal anti-inflammatory drug	123
Icatibant	Bradykinin B2 receptor antagonist	27
Infliximab	Tumor necrosis factor blocker	17
Ioversol	Radiographic contrast agent	12
Keytruda	Programmed death Receptor-1 blocking antibody	16
Lamictal	Anti-epileptic agent	18
Lamotrigine	Anti-epileptic agent	10
Lansoprazole	Proton pump inhibitor	14
Letrozole	Aromatase inhibitor	21
Levofloxacin	Fluoroquinolone antibacterial	42
Lidocaine	Amide local anesthetic	13
Lisinopril	Angiotensin converting enzyme inhibitor	86
Lyrica		19
Mabthera		78
Methotrexate	Folate analog metabolic inhibitor	28
Methylprednisolone	Corticosteroid	23
MultiHance	Gadolinium-based contrast agent	21
Nexium	Proton pump inhibitor	10
Nucala	Interleukin-5 antagonist	12
Nystatin		11
Ocrevus	CD20-directed cytolytic antibody	13
Omalizumab	Anti-IgE	22
Omeprazole	Proton pump inhibitor	19
Omnipaque	Radiographic contrast agent	53
Ondansetron	Serotonin-3 receptor antagonist	10
Optiray	Radiographic contrast agent	22
Oxaliplatin	Platinum-based drug	158
Paclitaxel	Microtubule inhibitor	53
Pantoprazole	Proton pump inhibitor	10
Paracetamol		22
Pembrolizumab	Programmed death Receptor-1 blocking antibody	16
Prednisone	Corticosteroid	28
Propofol	General anesthetic	28
Ramipril	Angiotensin converting enzyme inhibitor	68
Ranitidine	Histamine-2 receptor antagonist	14
Remicade	Tumor necrosis factor blocker	105
Rituximab	CD20-directed cytolytic antibody	51
Ruconest		23
Seretide		12
Sevoflurane	General anesthetic	11
Symbicort	Corticosteroid	15
Takhzyro	Plasma kallikrein inhibitor	20
Tazocin		13
Trastuzumab	HER2/neu receptor antagonist	11
Truxima	CD20-directed cytolytic antibody	13
Ultravist	Radiographic contrast agent	115
Vancomycin	Glycopeptide antibacterial	15
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	12
Visipaque	Radiographic contrast agent	14
Xolair	Anti-IgE	91
Xylocaine (lidocaine hcl )	Amide local anesthetic	10
Zyprexa	Atypical antipsychotic	11

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 34 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 Laryngeal oedema name, in order of name
Class	Reports with this term
Alkylating drug	37
Amide local anesthetic	27
Angiotensin 2 receptor blocker	83
Angiotensin converting enzyme inhibitor	187
Anti-epileptic agent	44
Anti-IgE	118
Aromatase inhibitor	25
Atypical antipsychotic	33
beta-Adrenergic blocker	35
Bradykinin B2 receptor antagonist	131
CD20-directed cytolytic antibody	84
CD38-directed cytolytic antibody	27
Cephalosporin antibacterial	25
Corticosteroid	155
Epidermal growth factor receptor antagonist	38
Fluoroquinolone antibacterial	56
Folate analog metabolic inhibitor	39
Gadolinium-based contrast agent	63
General anesthetic	53
Histamine-1 receptor antagonist	25
HMG-CoA reductase inhibitor	27
Human C1 esterase inhibitor	82
Interleukin-6 receptor antagonist	28
Kinase inhibitor	63
Microtubule inhibitor	106
Nonsteroidal anti-inflammatory drug	272
Nucleoside metabolic inhibitor	75
Penicillin-class antibacterial	90
Plasma kallikrein inhibitor	26
Platinum-based drug	264
Programmed death Receptor-1 blocking antibody	44
Proton pump inhibitor	60
Radiographic contrast agent	222
Tumor necrosis factor blocker	178

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

Reports by month

Reports that record Laryngeal oedema, 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 Laryngeal oedema
Age	Reports	Share
Under 2	31	0.5%
2 to 11	117	1.9%
12 to 17	100	1.7%
18 to 44	1,197	19.8%
45 to 64	1,732	28.6%
65 to 74	820	13.6%
75 and over	563	9.3%
Age not given	1,490	24.6%

Sex of the patient in the reports that record Laryngeal oedema
Sex	Reports	Share
Female	3,424	56.6%
Male	2,042	33.8%
Unknown or not given	584	9.7%

Age and sex are as the report gives them. 17.6% 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. Laryngeal oedema: adverse event reports that record this term. https://reportedreactions.com/reaction/laryngeal-oedema/ 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.

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 Laryngeal oedema mean in an adverse event report?

In plain words: swelling of the voice box. 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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