Sensation of foreign body 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 8,254 adverse event reports that record the MedDRA preferred term Sensation of foreign body. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 583 reports in the 12 months to June 2026 and 490 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 900 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, 583 (under 0.1%) record this term. Reports for female patients were 68.8% 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 99 drug pages with 25 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 Sensation of foreign body name as a suspect product, in order of name
Drug	Class	Reports with this term
Advil	Nonsteroidal anti-inflammatory drug	25
Albuterol	beta2-Adrenergic agonist	59
Albuterol sulfate	beta2-Adrenergic agonist	96
Aleve	Nonsteroidal anti-inflammatory drug	60
Alirocumab	PCSK9 inhibitor	31
Ambroxol hydrochloride		117
Amoxicillin	Penicillin-class antibacterial	32
Aspirin	Nonsteroidal anti-inflammatory drug	143
Belantamab mafodotin		32
Biotin	Arteriolar vasodilator	117
Bisoprolol	beta-Adrenergic blocker	99
Bisoprolol fumarate	beta-Adrenergic blocker	30
BOTOX Cosmetic	Acetylcholine release inhibitor	29
Byetta	GLP-1 receptor agonist	33
Calcium		70
Calcium carbonate	Blood coagulation factor	89
Calcium Pantothenate		89
Chantix	Partial cholinergic nicotinic agonist	33
Cialis	Phosphodiesterase 5 inhibitor	77
Clopidogrel	P2Y12 platelet inhibitor	75
Clopidogrel bisulfate	P2Y12 platelet inhibitor	81
Colesevelam hydrochloride		108
Commit		42
Cosentyx	Interleukin-17A antagonist	69
Crestor	HMG-CoA reductase inhibitor	89
Cymbalta		30
Diazepam	Benzodiazepine	29
Diclofenac	Nonsteroidal anti-inflammatory drug	91
Diclofenac diethylamine		80
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	49
Dietary Supplement		57
Dupixent	Interleukin-4 receptor alpha antagonist	85
Enbrel	Tumor necrosis factor blocker	100
Ergocalciferol	Provitamin D2 compound	108
Evolocumab	PCSK9 inhibitor	33
Fluoxetine	Serotonin reuptake inhibitor	28
Fluticasone propionate	Corticosteroid	40
Fluticasone Propionate Salmeterol Xinafoate		102
Forteo	Parathyroid hormone analog	37
Ginkgo		100
Herbals		109
Humira		169
Ibrance	Kinase inhibitor	29
Ibuprofen	Nonsteroidal anti-inflammatory drug	146
Inflectra	Tumor necrosis factor blocker	38
Infliximab	Tumor necrosis factor blocker	30
Ipratropium bromide	Anticholinergic	112
Levoxyl	l-Thyroxine	28
Lisinopril	Angiotensin converting enzyme inhibitor	33
Methotrexate	Folate analog metabolic inhibitor	39
Mirena	Progestin	27
Mirtazapine		27
Mometasone	Corticosteroid	94
Mometasone furoate	Corticosteroid	116
Mounjaro	GLP-1 receptor agonist	43
Nexium	Proton pump inhibitor	136
Nicotine polacrilex	Cholinergic nicotinic agonist	32
Ocrevus	CD20-directed cytolytic antibody	44
Olmesartan medoxomil	Angiotensin 2 receptor blocker	44
Omalizumab	Anti-IgE	32
Omeprazole	Proton pump inhibitor	33
Omnipaque	Radiographic contrast agent	44
Oxaliplatin	Platinum-based drug	83
Ozempic	GLP-1 receptor agonist	33
Palforzia		26
ParaGard T 380A	Copper-containing intrauterine device	1,181
Paxlovid		27
Pradaxa	Direct thrombin inhibitor	122
Praluent	PCSK9 inhibitor	116
Prilosec OTC	Proton pump inhibitor	32
Ramipril	Angiotensin converting enzyme inhibitor	30
Remicade	Tumor necrosis factor blocker	65
Repatha	PCSK9 inhibitor	97
Revlimid	Thalidomide analog	30
Rituximab	CD20-directed cytolytic antibody	48
Rivaroxaban	Factor Xa inhibitor	70
Rosuvastatin	HMG-CoA reductase inhibitor	39
Rosuvastatin calcium	HMG-CoA reductase inhibitor	90
Salmeterol		31
Salmeterol xinafoate	beta2-Adrenergic agonist	30
Sertraline	Serotonin reuptake inhibitor	47
Symbicort	Corticosteroid	67
Tadalafil	Phosphodiesterase 5 inhibitor	108
Tamsulosin		71
Tamsulosin hydrochloride	alpha-Adrenergic blocker	58
Tecfidera		25
Tiotropium bromide	Anticholinergic	48
Tocopherol		95
Trulicity	GLP-1 receptor agonist	29
Tysabri	Integrin receptor antagonist	28
Ultravist	Radiographic contrast agent	37
Victoza	GLP-1 receptor agonist	27
Vitamin d	Provitamin D2 compound	33
Vitamin e	Vitamin C	53
Xarelto	Factor Xa inhibitor	120
Xeljanz	Janus kinase inhibitor	47
Xolair	Anti-IgE	95
Xyrem	Central nervous system depressant	29
Zepbound	GLP-1 receptor agonist	30

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 51 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 Sensation of foreign body name, in order of name
Class	Reports with this term
Acetylcholine release inhibitor	54
alpha-Adrenergic blocker	65
Angiotensin 2 receptor blocker	77
Angiotensin converting enzyme inhibitor	67
Anti-IgE	127
Anticholinergic	192
Arteriolar vasodilator	117
Atypical antipsychotic	70
Benzodiazepine	68
beta-Adrenergic blocker	137
beta2-Adrenergic agonist	187
Bisphosphonate	30
Blood coagulation factor	89
Calcineurin inhibitor immunosuppressant	35
CD20-directed cytolytic antibody	137
Central nervous system depressant	40
Cholinergic nicotinic agonist	63
Copper-containing intrauterine device	1,181
Corticosteroid	485
Direct thrombin inhibitor	122
Factor Xa inhibitor	199
Fluoroquinolone antibacterial	29
Folate analog metabolic inhibitor	47
Gadolinium-based contrast agent	36
GLP-1 receptor agonist	210
HMG-CoA reductase inhibitor	232
Integrin receptor antagonist	56
Interleukin-17A antagonist	76
Interleukin-4 receptor alpha antagonist	85
Janus kinase inhibitor	70
Kinase inhibitor	98
l-Thyroxine	65
Nonsteroidal anti-inflammatory drug	544
Nucleoside metabolic inhibitor	27
P2Y12 platelet inhibitor	160
Parathyroid hormone analog	37
Partial cholinergic nicotinic agonist	33
PCSK9 inhibitor	277
Penicillin-class antibacterial	34
Phosphodiesterase 5 inhibitor	187
Platinum-based drug	111
Progestin	34
Prostacycline vasodilator	35
Proton pump inhibitor	282
Provitamin D2 compound	141
Radiographic contrast agent	92
Serotonin and norepinephrine reuptake inhibitor	44
Serotonin reuptake inhibitor	107
Thalidomide analog	40
Tumor necrosis factor blocker	240
Vitamin C	56

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

Reports by month

Reports that record Sensation of foreign body, 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 Sensation of foreign body
Age	Reports	Share
Under 2	3	under 0.1%
2 to 11	60	0.7%
12 to 17	136	1.6%
18 to 44	2,009	24.3%
45 to 64	1,846	22.4%
65 to 74	828	10%
75 and over	596	7.2%
Age not given	2,776	33.6%

Sex of the patient in the reports that record Sensation of foreign body
Sex	Reports	Share
Female	5,678	68.8%
Male	1,740	21.1%
Unknown or not given	836	10.1%

Age and sex are as the report gives them. 66.7% 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. Sensation of foreign body: adverse event reports that record this term. https://reportedreactions.com/reaction/sensation-of-foreign-body/ 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 Sensation of foreign body 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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