MedDRA preferred term · swelling of the throat

Pharyngeal oedema: adverse event reports recording this term

15,372 reports to FDA record it, 2004–2026; 0.1% of the database.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

15,372
reports recording the term: 0.1% of all reports; 65
reports, 12 months to June 2026: 81 in the 12 months before; 75.7%
marked serious by the reporter: 57.4% across all reports; 1.5%
record death among outcomes, as reported: 9.1% across all reports

"Pharyngeal oedema" (in plain words, swelling of the throat) is a MedDRA preferred term recorded in 15,372 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

65 reports recorded it in the 12 months to June 2026, down 20% from 81 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 75.7% are marked serious, 1.5% include death among the outcomes and 22.4% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humira, Enbrel and Lyrica. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Humira	—	517	0.1%
Enbrel	Tumor necrosis factor blocker	496	0.1%
Lyrica	—	288	0.2%
Lisinopril	Angiotensin converting enzyme inhibitor	248	0.6%
Xolair	Anti-IgE	198	0.3%
Cinryze	Human C1 esterase inhibitor	186	7%
Chantix	Partial cholinergic nicotinic agonist	182	0.3%
Methotrexate	Folate analog metabolic inhibitor	176	0.1%
Celebrex	Nonsteroidal anti-inflammatory drug	165	0.4%
Remicade	Tumor necrosis factor blocker	156	0.1%
Tiotropium bromide	Anticholinergic	139	0.2%
Copaxone	—	136	0.3%
Rituxan	CD20-directed cytolytic antibody	124	0.3%
Actemra	Interleukin-6 receptor antagonist	123	0.2%
Aleve	Nonsteroidal anti-inflammatory drug	121	0.2%
Avelox	—	116	0.8%
Ramipril	Angiotensin converting enzyme inhibitor	114	0.3%
Heparin sodium	Anti-coagulant	106	0.8%
Ibuprofen	Nonsteroidal anti-inflammatory drug	105	0.1%
Firazyr	Bradykinin B2 receptor antagonist	104	3.4%
Tecfidera	—	95	0.1%
Xeljanz	Janus kinase inhibitor	94	0.1%
Simponi	Tumor necrosis factor blocker	90	0.1%
Prednisone	Corticosteroid	87	0%
Amoxicillin	Penicillin-class antibacterial	86	0.3%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.1% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Tumor necrosis factor blocker	833	0.1%	0%
Nonsteroidal anti-inflammatory drug	680	0.1%	0%
Angiotensin converting enzyme inhibitor	454	0.4%	0.4%
Corticosteroid	451	0.1%	0%
Proton pump inhibitor	287	0.1%	0%
Atypical antipsychotic	244	0%	0%
Angiotensin 2 receptor blocker	232	0.1%	0.1%
Folate analog metabolic inhibitor	228	0.1%	0%
Anti-IgE	227	0.3%	0.3%
CD20-directed cytolytic antibody	217	0.1%	0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.1%22

2 to 110.8%129

12 to 171.5%223

18 to 4419.7%3,023

45 to 6428.3%4,348

65 to 7410.4%1,593

75 and over6.5%1,002

Age not given32.7%5,032

Patient sex

Female67.2%10,329

Male26.8%4,126

Not given6%917

Grey bar: all 20,646,523 reports in the database. 67.5% of these reports give the United States as the country.

Questions about "Pharyngeal oedema"

What does "Pharyngeal oedema" mean in an adverse event report?

In plain language: swelling of the throat. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record pharyngeal oedema?

15,372 reports through June 2026 (0.1% of all reports), 65 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humira (517), Enbrel (496), Lyrica (288), Lisinopril (248) and Xolair (198). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.