Sinus headache 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 5,884 adverse event reports that record the MedDRA preferred term Sinus headache. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 216 reports in the 12 months to June 2026 and 203 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 1,316 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, 216 (under 0.1%) record this term. Reports for female patients were 71.5% of the reports that record this term and 52.7% 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.

Data version

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

Drugs in these reports

The table has the 117 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 Sinus headache name as a suspect product, in order of name
Drug	Class	Reports with this term
Actemra	Interleukin-6 receptor antagonist	14
Adcirca	Phosphodiesterase 5 inhibitor	13
Adempas	Soluble guanylate cyclase stimulator	10
Alendronate sodium	Bisphosphonate	12
Aleve	Nonsteroidal anti-inflammatory drug	22
Allegra		17
Ambrisentan	Endothelin receptor antagonist	23
Ampyra	Potassium channel blocker	14
Arava	Antirheumatic agent	28
Aredia		18
Aubagio	Pyrimidine synthesis inhibitor	11
Avastin	Vascular endothelial growth factor inhibitor	13
Avonex	Interferon beta	29
Benadryl	Histamine-1 receptor antagonist	13
BOTOX Cosmetic	Acetylcholine release inhibitor	23
Byetta	GLP-1 receptor agonist	32
Captopril	Angiotensin converting enzyme inhibitor	12
Chantix	Partial cholinergic nicotinic agonist	20
Cialis	Phosphodiesterase 5 inhibitor	18
Cimzia	Tumor necrosis factor blocker	31
Cortisone acetate	Corticosteroid	12
Cosentyx	Interleukin-17A antagonist	54
Crestor	HMG-CoA reductase inhibitor	21
Cyclophosphamide	Alkylating drug	13
Cymbalta		14
Desoximetasone	Corticosteroid	27
Digoxin	Cardiac glycoside	22
Diphenhydramine	Histamine-1 receptor antagonist	11
Diphenhydramine hydrochloride	Histamine-1 receptor antagonist	16
Dupixent	Interleukin-4 receptor alpha antagonist	192
Effexor	Serotonin and norepinephrine reuptake inhibitor	10
Eliquis	Factor Xa inhibitor	24
Emgality		13
Enbrel	Tumor necrosis factor blocker	757
Entresto	Angiotensin 2 receptor blocker	14
Flonase	Corticosteroid	41
Fluticasone propionate	Corticosteroid	16
Forteo	Parathyroid hormone analog	45
Fosamax	Bisphosphonate	38
Gabapentin	Anti-epileptic agent	13
Gilenya	Sphingosine 1-phosphate receptor modulator	46
Hizentra	Human immunoglobulin G	10
Human immunoglobulin g	Human immunoglobulin G	30
Humira		528
Humira 40 Mg/0 8 Ml Pen		52
Hydrochlorothiazide	Thiazide diuretic	10
Ibrance	Kinase inhibitor	16
Ibuprofen	Nonsteroidal anti-inflammatory drug	36
Imbruvica	Kinase inhibitor	11
Incivek		18
Inflectra	Tumor necrosis factor blocker	15
Infliximab	Tumor necrosis factor blocker	10
Jakafi	Janus kinase inhibitor	21
Kesimpta	CD20-directed cytolytic antibody	10
Letairis	Endothelin receptor antagonist	37
Loratadine		11
Lyrica		28
Methotrexate	Folate analog metabolic inhibitor	34
Methylprednisolone sodium succinate	Corticosteroid	10
Metoprolol	beta-Adrenergic blocker	13
Moxonidine		12
Nasacort Allergy 24HR	Corticosteroid	14
Nasonex	Corticosteroid	13
Neulasta	Leukocyte growth factor	17
Nexium	Proton pump inhibitor	27
Niaspan		12
Nuvaring	Estrogen	13
Ocrevus	CD20-directed cytolytic antibody	19
Ofev	Kinase inhibitor	20
Omalizumab	Anti-IgE	17
Opsumit	Endothelin receptor antagonist	44
Orencia	Selective T cell costimulation modulator	18
Orenitram	Prostacycline vasodilator	41
Otezla	Phosphodiesterase 4 inhibitor	126
Oxervate		16
Paxlovid		30
Pegasys	Interferon alpha	33
Praluent	PCSK9 inhibitor	16
Prednisone	Corticosteroid	49
Prolia	RANK ligand inhibitor	10
Remicade	Tumor necrosis factor blocker	11
Remodulin	Prostacycline vasodilator	36
Repatha	PCSK9 inhibitor	44
Restasis	Calcineurin inhibitor immunosuppressant	18
Revlimid	Thalidomide analog	47
Ribavirin	Nucleoside analog antiviral	25
Rinvoq	Janus kinase inhibitor	20
Rituxan	CD20-directed cytolytic antibody	14
Rituximab	CD20-directed cytolytic antibody	30
Sertraline	Serotonin reuptake inhibitor	16
Singulair	Leukotriene receptor antagonist	26
Skyrizi	Interleukin-23 antagonist	15
Soliris	Complement inhibitor	29
Solu-medrol	Corticosteroid	21
Sulfasalazine	Aminosalicylate	34
Symbicort	Corticosteroid	14
Tecfidera		38
Tiotropium bromide	Anticholinergic	36
Trikafta		26
Tymlos		26
Tysabri	Integrin receptor antagonist	92
Tyvaso	Prostacycline vasodilator	28
Tyvaso DPI	Prostacycline vasodilator	32
Uptravi	Prostacyclin receptor agonist	17
Valsartan	Angiotensin 2 receptor blocker	12
Vedolizumab	Integrin receptor antagonist	15
Veletri	Prostacycline vasodilator	10
Veramyst		15
Verapamil hydrochloride	Calcium channel blocker	11
Vyepti		12
Xarelto	Factor Xa inhibitor	18
Xeljanz	Janus kinase inhibitor	93
Xhance	Corticosteroid	20
Xolair	Anti-IgE	72
Xyrem	Central nervous system depressant	60
Zometa		32
Zyrtec	Histamine-1 receptor antagonist	16

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 39 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 Sinus headache name, in order of name
Class	Reports with this term
Acetylcholine release inhibitor	29
Aminosalicylate	34
Angiotensin 2 receptor blocker	28
Anti-IgE	89
Anticholinergic	42
Antirheumatic agent	34
beta-Adrenergic blocker	26
Bisphosphonate	59
CD20-directed cytolytic antibody	75
Central nervous system depressant	64
Complement inhibitor	31
Corticosteroid	266
Endothelin receptor antagonist	110
Factor Xa inhibitor	52
Folate analog metabolic inhibitor	43
GLP-1 receptor agonist	51
Histamine-1 receptor antagonist	79
HMG-CoA reductase inhibitor	26
Human immunoglobulin G	44
Integrin receptor antagonist	111
Interferon alpha	33
Interferon beta	29
Interleukin-17A antagonist	57
Interleukin-4 receptor alpha antagonist	194
Janus kinase inhibitor	134
Kinase inhibitor	83
Leukotriene receptor antagonist	30
Nonsteroidal anti-inflammatory drug	79
Nucleoside analog antiviral	27
Parathyroid hormone analog	45
PCSK9 inhibitor	60
Phosphodiesterase 4 inhibitor	126
Phosphodiesterase 5 inhibitor	46
Prostacycline vasodilator	154
Proton pump inhibitor	49
Serotonin reuptake inhibitor	39
Sphingosine 1-phosphate receptor modulator	48
Thalidomide analog	49
Tumor necrosis factor blocker	835

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

Reports by month

Reports that record Sinus headache, 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 Sinus headache
Age	Reports	Share
Under 2	1	under 0.1%
2 to 11	19	0.3%
12 to 17	33	0.6%
18 to 44	941	16%
45 to 64	1,897	32.2%
65 to 74	638	10.8%
75 and over	261	4.4%
Age not given	2,094	35.6%

Sex of the patient in the reports that record Sinus headache
Sex	Reports	Share
Female	4,208	71.5%
Male	1,316	22.4%
Unknown or not given	360	6.1%

Age and sex are as the report gives them. 88.7% 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. Sinus headache: adverse event reports that record this term. https://reportedreactions.com/reaction/sinus-headache/ 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 Sinus headache 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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