Reported Reactions

Adverse event reports that FDA received

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Foreign body sensation in eyes 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 . The data have the reports that FDA received through .

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 .

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 .

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 May 2005 to June 2026, FDA received 6,161 adverse event reports that record the MedDRA preferred term Foreign body sensation in eyes. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 579 reports in the 12 months to June 2026 and 397 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 902 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, 579 (under 0.1%) record this term. Reports for female patients were 68.1% 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 142 drug pages with 5 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 .

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 . The site read the page on .

Drugs that the reports with the term Foreign body sensation in eyes name as a suspect product, in order of name
DrugClassReports with this term
Aclasta6
Acoltremon45
AdalimumabTumor necrosis factor blocker7
AlawayHistamine-1 receptor inhibitor5
Albuterolbeta2-Adrenergic agonist14
AllopurinolXanthine oxidase inhibitor6
Alphagan Palpha-Adrenergic agonist45
AvastinVascular endothelial growth factor inhibitor37
AzoptCarbonic anhydrase inhibitor41
Belantamab mafodotin167
Beovu19
BesivanceQuinolone antimicrobial21
Betadine22
Blenrep11
BortezomibProteasome inhibitor9
BotoxAcetylcholine release inhibitor8
BOTOX CosmeticAcetylcholine release inhibitor17
Brimonidinealpha-Adrenergic agonist7
Brimonidine tartratealpha-Adrenergic agonist15
Brolucizumab13
BromfenacNonsteroidal anti-inflammatory drug6
BssOsmotic laxative5
BudesonideCorticosteroid14
CarboplatinPlatinum-based drug17
CequaCalcineurin inhibitor immunosuppressant14
CiprofloxacinFluoroquinolone antibacterial22
ColchicineAlkaloid5
Combiganalpha-Adrenergic agonist53
Combigan R14
Corticotropin8
CosentyxInterleukin-17A antagonist7
CosoptCarbonic anhydrase inhibitor6
Cosopt PfCarbonic anhydrase inhibitor31
CyclophosphamideAlkylating drug6
CyclosporineCalcineurin inhibitor immunosuppressant14
DexamethasoneCorticosteroid7
Diclofenac sodiumNonsteroidal anti-inflammatory drug12
DocetaxelMicrotubule inhibitor24
Dorzolamide hydrochloride and timolol maleateCarbonic anhydrase inhibitor5
Dorzolamide hydrochloride timolol maleateCarbonic anhydrase inhibitor5
DoxycyclineTetracycline-class drug9
Doxycycline hyclateTetracycline-class drug11
DupilumabInterleukin-4 receptor alpha antagonist35
DupixentInterleukin-4 receptor alpha antagonist301
Durezol16
EnbrelTumor necrosis factor blocker42
Erythromycin17
EyleaVascular endothelial growth factor inhibitor127
FosamaxBisphosphonate13
GabapentinAnti-epileptic agent5
Genteal Mild20
GilenyaSphingosine 1-phosphate receptor modulator14
GlycopyrrolateAnticholinergic14
HerceptinHER2/neu receptor antagonist17
Humira49
Hyaluronate sodium5
Hydralazine17
IlevroNonsteroidal anti-inflammatory drug14
Ipratropium bromideAnticholinergic16
Ketorolac tromethamine8
Lacrisert14
LastacaftHistamine-1 receptor antagonist16
LatanoprostProstaglandin analog122
Latanoprost ophthalmic solution 0.005%Prostaglandin analog28
LatisseProstaglandin analog64
Latisse 0 03%15
LevofloxacinFluoroquinolone antibacterial10
Levofloxacin hemihydrate10
LotemaxCorticosteroid59
LucentisVascular endothelial growth factor inhibitor105
Lumify65
LumiganProstaglandin analog94
Lumigan 0 01%16
MaxitrolCorticosteroid5
MethotrexateFolate analog metabolic inhibitor9
Miebo34
Mirtazapine7
NevanacNonsteroidal anti-inflammatory drug14
OmalizumabAnti-IgE28
Opcon-A13
Oxervate489
Pataday26
Pataday Once Daily ReliefHistamine-1 receptor antagonist21
PegasysInterferon alpha9
PerjetaHER2/neu receptor antagonist11
Phenylephrine hclalpha-1 adrenergic agonist8
PomalidomideThalidomide analog23
Pred ForteCorticosteroid17
PrednisoloneCorticosteroid9
Prednisolone acetateCorticosteroid13
PrednisoneCorticosteroid29
ProlensaNonsteroidal anti-inflammatory drug22
Pulmicort Turbuhaler14
RamiprilAngiotensin converting enzyme inhibitor10
RanibizumabVascular endothelial growth factor inhibitor13
Refresh Celluvisc12
Refresh Classic8
Refresh OptiveNon-Standardized chemical allergen68
REFRESH OPTIVE AdvancedNon-Standardized chemical allergen16
Refresh Optive Sensitive29
Refresh Plus14
Refresh Tears18
Refresh Tears PfNon-Standardized chemical allergen6
RestasisCalcineurin inhibitor immunosuppressant922
Rhopressa10
RibavirinNucleoside analog antiviral9
RituximabCD20-directed cytolytic antibody24
SertralineSerotonin reuptake inhibitor10
SimbrinzaCarbonic anhydrase inhibitor31
SkyriziInterleukin-23 antagonist8
SulfasalazineAminosalicylate18
Systane227
Systane Balance113
Systane COMPLETE13
Systane Geldrops125
Systane Lubricant20
Systane Nighttime74
Systane Pf126
Systane Ultra179
TasignaKinase inhibitor5
Tepezza14
Timololbeta-Adrenergic blocker12
Timolol maleatebeta-Adrenergic blocker17
Tiotropium bromideAnticholinergic15
TobraDexAminoglycoside antibacterial21
Topamax5
Travatan7
Travatan ZProstaglandin analog38
TravoprostProstaglandin analog6
TyrvayaCholinergic receptor agonist11
TysabriIntegrin receptor antagonist10
UpneeqVasoconstrictor28
Vabysmo32
VevyeCalcineurin inhibitor immunosuppressant78
VigamoxFluoroquinolone antibacterial24
VizzCholinergic receptor agonist12
Vyzulta11
XalatanProstaglandin analog89
Xdemvy37
Xiidra145
ZaditorHistamine-1 receptor inhibitor10
ZioptanProstaglandin analog27

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 50 pharmacologic classes with 5 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 .

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 . The site read the page on .

Pharmacologic classes of the drugs that the reports with the term Foreign body sensation in eyes name, in order of name
ClassReports with this term
Acetylcholine release inhibitor25
Alkaloid5
Alkylating drug6
alpha-Adrenergic agonist120
Aminoglycoside antibacterial25
Aminosalicylate18
Angiotensin converting enzyme inhibitor10
Anti-epileptic agent10
Anti-IgE30
Anticholinergic50
Aromatase inhibitor7
beta-Adrenergic blocker37
beta2-Adrenergic agonist14
Bisphosphonate13
Calcineurin inhibitor immunosuppressant1,028
Carbonic anhydrase inhibitor116
CD20-directed cytolytic antibody26
CD38-directed cytolytic antibody5
Cholinergic receptor agonist23
Corticosteroid165
Fluoroquinolone antibacterial62
Folate analog metabolic inhibitor11
GLP-1 receptor agonist7
HER2/neu receptor antagonist28
Histamine-1 receptor antagonist39
Histamine-1 receptor inhibitor15
Integrin receptor antagonist10
Interferon alpha9
Interleukin-17A antagonist9
Interleukin-23 antagonist8
Interleukin-4 receptor alpha antagonist336
Janus kinase inhibitor8
Kinase inhibitor20
Microtubule inhibitor24
Non-Standardized chemical allergen68
Nonsteroidal anti-inflammatory drug53
Nucleoside analog antiviral9
Osmotic laxative5
Phosphodiesterase 5 inhibitor7
Platinum-based drug20
Prostaglandin analog468
Proteasome inhibitor15
Serotonin reuptake inhibitor10
Sphingosine 1-phosphate receptor modulator14
Tetracycline-class drug20
Thalidomide analog28
Tumor necrosis factor blocker63
Vascular endothelial growth factor inhibitor288
Vasoconstrictor28
Xanthine oxidase inhibitor6

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

Reports by month

Reports that record Foreign body sensation in eyes, by month, five years to June 2026
010020020222023202420252026

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 Foreign body sensation in eyes
AgeReportsShareShare as a bar
Under 23under 0.1%
2 to 1170.1%
12 to 1780.1%
18 to 443355.4%
45 to 641,00016.2%
65 to 7486114%
75 and over88214.3%
Age not given3,06549.7%
Sex of the patient in the reports that record Foreign body sensation in eyes
SexReportsShareShare as a bar
Female4,19868.1%
Male1,44323.4%
Unknown or not given5208.4%

Age and sex are as the report gives them. 85.8% of these reports give the United States as the country.

Terms near this one

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

Reported Reactions. Foreign body sensation in eyes: adverse event reports that record this term. https://reportedreactions.com/reaction/foreign-body-sensation-in-eyes/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

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 Foreign body sensation in eyes 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 .

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 .

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 .