Reported Reactions

Adverse event reports that FDA received

  • Search
  • Watch list

Accidental exposure to product 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 March 2005 to June 2026, FDA received 98,588 adverse event reports that record the MedDRA preferred term Accidental exposure to product. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 12,705 reports in the 12 months to June 2026 and 12,198 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 37 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, 12,705 (1%) record this term. Reports for female patients were 60.5% 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 140 drug pages with 50 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 Accidental exposure to product name as a suspect product, in order of name
DrugClassReports with this term
AbrevaNon-Standardized chemical allergen91
Acetaminophen240
ActemraInterleukin-6 receptor antagonist290
AdalimumabTumor necrosis factor blocker154
Adalimumab-aaty66
Aimovig10,196
Ajovy1,442
Albuterol sulfatebeta2-Adrenergic agonist144
Alcohol86
Alphagan Palpha-Adrenergic agonist66
AlprazolamBenzodiazepine84
AmjevitaTumor necrosis factor blocker147
AmlodipineCalcium channel blocker86
Androgel196
AranespErythropoiesis-stimulating agent95
AsmanexCorticosteroid54
Auvi-qCatecholamine146
Axiron91
BenlystaB lymphocyte stimulator-specific inhibitor997
Bimzelx143
Blincyto192
BotoxAcetylcholine release inhibitor75
BOTOX CosmeticAcetylcholine release inhibitor87
BuprenorphinePartial opioid agonist51
BupropionAminoketone177
Childrens MOTRINNonsteroidal anti-inflammatory drug130
Childrens TYLENOLSigma-1 agonist71
Chloraprep with Tint57
ClonazepamBenzodiazepine87
ClozapineAtypical antipsychotic94
Combiganalpha-Adrenergic agonist144
CosentyxInterleukin-17A antagonist2,762
DaytranaCentral nervous system stimulant164
DexamethasoneCorticosteroid60
Dianeal Low Calcium80
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose94
DiazepamBenzodiazepine64
DiclofenacNonsteroidal anti-inflammatory drug68
Diclofenac sodiumNonsteroidal anti-inflammatory drug308
DiphenhydramineHistamine-1 receptor antagonist57
DupilumabInterleukin-4 receptor alpha antagonist437
DupixentInterleukin-4 receptor alpha antagonist15,376
EligardGonadotropin releasing hormone receptor agonist106
Emgality89
EnbrelTumor necrosis factor blocker6,364
EpinephrineCatecholamine248
EpipenCatecholamine427
Epipen JrCatecholamine79
Evenity55
FasenraInterleukin-5 receptor alpha-directed cytolytic antibody51
FentanylOpioid agonist190
Fentanyl citrateOpioid agonist79
FlonaseCorticosteroid146
Flonase Allergy Relief76
Flonase Sensimist Allergy Relief57
Fluticasone propionateCorticosteroid53
GabapentinAnti-epileptic agent71
Genotropin692
Glatopa99
GuselkumabInterleukin-23 antagonist310
HadlimaTumor necrosis factor blocker57
HumalogInsulin analog236
Humatrope50
Humira513
HyrimozTumor necrosis factor blocker147
IbuprofenNonsteroidal anti-inflammatory drug193
Insulin glargineInsulin analog74
Invega SustennaAtypical antipsychotic171
IxazomibProteasome inhibitor78
KesimptaCD20-directed cytolytic antibody920
KevzaraInterleukin-6 receptor antagonist97
KyprolisProteasome inhibitor75
LamotrigineAnti-epileptic agent54
LantusInsulin analog191
Lantus SolostarInsulin analog776
LatanoprostProstaglandin analog69
Levulan Kerastick76
LidocaineAmide local anesthetic83
LorazepamBenzodiazepine64
Lumify66
LumiganProstaglandin analog156
Mens Rogaine Extra Strength88
MepolizumabInterleukin-5 antagonist86
MetforminBiguanide79
MethadoneOpioid agonist64
MethotrexateFolate analog metabolic inhibitor135
Metoprololbeta-Adrenergic blocker50
Miebo114
MinoxidilArteriolar vasodilator198
MvasiVascular endothelial growth factor inhibitor89
NeulastaLeukocyte growth factor4,946
NicoretteCholinergic nicotinic agonist94
Nicotine polacrilexCholinergic nicotinic agonist73
NinlaroProteasome inhibitor186
NplateThrombopoietin receptor agonist64
NucalaInterleukin-5 antagonist1,615
OmnitropeRecombinant human growth hormone211
OrenciaSelective T cell costimulation modulator296
OxycodoneOpioid agonist79
PegasysInterferon alpha200
Pegintron59
Picato137
PrednisoneCorticosteroid61
ProliaRANK ligand inhibitor1,204
QuetiapineAtypical antipsychotic71
RasuvoFolate analog metabolic inhibitor144
RemicadeTumor necrosis factor blocker102
RemodulinProstacycline vasodilator135
RepathaPCSK9 inhibitor16,755
RestasisCalcineurin inhibitor immunosuppressant642
RevlimidThalidomide analog58
Risperdal Consta652
Sandostatin LAR Depot116
SimponiTumor necrosis factor blocker1,701
Soliqua 100/33GLP-1 receptor agonist318
StelaraInterleukin-12 antagonist1,407
Sterile diluentInsulin analog50
Sumatriptan succinateSerotonin-1b and Serotonin-1d receptor agonist67
Sumavel Dosepro273
Tanzeum1,182
TestosteroneAndrogen51
Tezspire70
Tiotropium bromideAnticholinergic141
ToujeoInsulin analog98
TremfyaInterleukin-23 antagonist3,202
TrulicityGLP-1 receptor agonist126
TylenolExpectorant63
Ventolin Hfabeta2-Adrenergic agonist87
Voltaren Arthritis Pain111
WegovyGLP-1 receptor agonist77
Womens Rogaine68
Womens Rogaine UnscentedArteriolar vasodilator94
Xdemvy75
XgevaRANK ligand inhibitor134
Xiidra152
XolairAnti-IgE467
Xolair PFSAnti-IgE93
Yuflyma95
ZymfentraTumor necrosis factor blocker65
ZyrtecHistamine-1 receptor antagonist81

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 48 pharmacologic classes with 100 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 Accidental exposure to product name, in order of name
ClassReports with this term
Acetylcholine release inhibitor169
alpha-Adrenergic agonist268
Amide local anesthetic132
Aminoketone185
Androgen143
Anti-epileptic agent186
Anti-IgE572
Anticholinergic315
Arteriolar vasodilator292
Atypical antipsychotic600
B lymphocyte stimulator-specific inhibitor1,016
Benzodiazepine331
beta-Adrenergic blocker183
beta2-Adrenergic agonist242
Biguanide106
Calcineurin inhibitor immunosuppressant701
Catecholamine909
CD20-directed cytolytic antibody937
Central nervous system stimulant233
Cholinergic nicotinic agonist192
Corticosteroid897
Erythropoiesis-stimulating agent151
Folate analog metabolic inhibitor343
GLP-1 receptor agonist613
Gonadotropin releasing hormone receptor agonist106
Histamine-1 receptor antagonist328
Insulin analog1,541
Interferon alpha200
Interleukin-12 antagonist1,419
Interleukin-17A antagonist2,795
Interleukin-23 antagonist3,534
Interleukin-4 receptor alpha antagonist15,813
Interleukin-5 antagonist1,701
Interleukin-6 receptor antagonist429
Leukocyte growth factor5,079
Nonsteroidal anti-inflammatory drug1,000
Opioid agonist666
PCSK9 inhibitor16,804
Progestin142
Prostacycline vasodilator203
Prostaglandin analog319
Proteasome inhibitor351
RANK ligand inhibitor1,338
Recombinant human growth hormone249
Selective T cell costimulation modulator344
Serotonin reuptake inhibitor100
Tumor necrosis factor blocker8,802
Vascular endothelial growth factor inhibitor115

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

Reports by month

Reports that record Accidental exposure to product, by month, five years to June 2026
01,0002,00020222023202420252026

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 Accidental exposure to product
AgeReportsShareShare as a bar
Under 27490.8%
2 to 112,1852.2%
12 to 171,6021.6%
18 to 4412,95513.1%
45 to 6421,96222.3%
65 to 7413,20913.4%
75 and over9,0159.1%
Age not given36,91137.4%
Sex of the patient in the reports that record Accidental exposure to product
SexReportsShareShare as a bar
Female59,67960.5%
Male30,00830.4%
Unknown or not given8,9019%

Age and sex are as the report gives them. 95.2% 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

Embed this card on your site

Copy this code into your page. The card shows the figures above with their source. A line under the card links to this page.

How embedding works. It is free. Keep the link in the card and the link line under it.

Reported Reactions. Accidental exposure to product: adverse event reports that record this term. https://reportedreactions.com/reaction/accidental-exposure-to-product/ 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 Accidental exposure to product 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 .