MedDRA preferred term

Sinus disorder: adverse event reports recording this term

19,534 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.

19,534
reports recording the term: 0.1% of all reports; 1,020
reports, 12 months to June 2026: 1,119 in the 12 months before; 46.2%
marked serious by the reporter: 57.4% across all reports; 1.5%
record death among outcomes, as reported: 9.1% across all reports

"Sinus disorder" is a MedDRA preferred term recorded in 19,534 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.

1,020 reports recorded it in the 12 months to June 2026, close to the 1,119 of 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, 46.2% are marked serious, 1.5% include death among the outcomes and 19.2% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humira, Enbrel and Dupixent. 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	—	1,253	0.2%
Enbrel	Tumor necrosis factor blocker	1,233	0.2%
Dupixent	Interleukin-4 receptor alpha antagonist	814	0.2%
Prednisone	Corticosteroid	575	0.3%
Xeljanz	Janus kinase inhibitor	557	0.4%
Revlimid	Thalidomide analog	537	0.2%
Cosentyx	Interleukin-17A antagonist	425	0.3%
Repatha	PCSK9 inhibitor	378	0.2%
Fosamax	Bisphosphonate	353	1%
Methotrexate	Folate analog metabolic inhibitor	341	0.2%
Symbicort	Corticosteroid	306	0.8%
Tiotropium bromide	Anticholinergic	281	0.4%
Nucala	Interleukin-5 antagonist	271	0.9%
Rituximab	CD20-directed cytolytic antibody	269	0.2%
Human immunoglobulin g	Human immunoglobulin G	262	1.5%
Tysabri	Integrin receptor antagonist	255	0.1%
Ergocalciferol	Provitamin D2 compound	245	2.4%
Xyrem	Central nervous system depressant	243	0.4%
Letairis	Endothelin receptor antagonist	225	0.5%
Albuterol sulfate	beta2-Adrenergic agonist	222	0.5%
Entresto	Angiotensin 2 receptor blocker	220	0.2%
Nexium	Proton pump inhibitor	217	0.3%
Lipitor	HMG-CoA reductase inhibitor	215	0.4%
Bisoprolol	beta-Adrenergic blocker	204	0.9%
Calcium carbonate	Blood coagulation factor	202	2.3%

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
Corticosteroid	2,035	0.3%	0%
Tumor necrosis factor blocker	1,650	0.2%	0.1%
Interleukin-4 receptor alpha antagonist	848	0.2%	0.3%
Angiotensin 2 receptor blocker	808	0.3%	0%
Proton pump inhibitor	801	0.2%	0.1%
Janus kinase inhibitor	785	0.2%	0%
Thalidomide analog	710	0.1%	0.2%
Endothelin receptor antagonist	697	0.4%	0.4%
Kinase inhibitor	680	0.1%	0%
Histamine-1 receptor antagonist	616	0.5%	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%13

2 to 110.5%89

12 to 170.6%119

18 to 449.4%1,845

45 to 6428%5,465

65 to 7415%2,931

75 and over8.1%1,576

Age not given38.4%7,496

Patient sex

Female67.7%13,219

Male26.4%5,160

Not given5.9%1,155

Grey bar: all 20,646,523 reports in the database. 86.4% of these reports give the United States as the country.

Questions about "Sinus disorder"

What does "Sinus disorder" mean in an adverse event report?

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 sinus disorder?

19,534 reports through June 2026 (0.1% of all reports), 1,020 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humira (1,253), Enbrel (1,233), Dupixent (814), Prednisone (575) and Xeljanz (557). 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.