Reported Reactions

Adverse event reports that FDA received

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Circumstance or information capable of leading to medication error adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
a situation that could lead to a medication error

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 April 2005 to June 2026, FDA received 33,110 adverse event reports that record the MedDRA preferred term Circumstance or information capable of leading to medication error. In plain words, the term means: a situation that could lead to a medication error. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 2,487 reports in the 12 months to June 2026 and 3,265 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 298 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, 2,487 (0.2%) record this term. Reports for female patients were 34.6% 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.

Plain meaning

A situation that could lead to a medication error. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

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

Drugs in these reports

The table has the 150 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 .

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 Circumstance or information capable of leading to medication error name as a suspect product, in order of name
DrugClassReports with this term
AbilifyAtypical antipsychotic58
AccutaneRetinoid61
Acetaminophen32
ActemraInterleukin-6 receptor antagonist49
Activase31
AdalimumabTumor necrosis factor blocker31
Advair DiskusCorticosteroid110
Advair HfaCorticosteroid34
AdvilNonsteroidal anti-inflammatory drug42
Aimovig986
Albuterolbeta2-Adrenergic agonist25
Albuterol sulfatebeta2-Adrenergic agonist336
AleveNonsteroidal anti-inflammatory drug132
AmjevitaTumor necrosis factor blocker194
Anoro ElliptaAnticholinergic197
ApixabanFactor Xa inhibitor29
AranespErythropoiesis-stimulating agent1,048
AsmanexCorticosteroid513
Asmanex HfaCorticosteroid68
Atenololbeta-Adrenergic blocker27
AvastinVascular endothelial growth factor inhibitor27
AvsolaTumor necrosis factor blocker99
BelimumabB lymphocyte stimulator-specific inhibitor52
BelsomraOrexin receptor antagonist61
BenlystaB lymphocyte stimulator-specific inhibitor149
Bevespi AerosphereAnticholinergic27
BiktarvyHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor61
Blincyto147
Breo ElliptaCorticosteroid222
BrilintaP2Y12 platelet inhibitor41
BudesonideCorticosteroid25
Bydureon443
Bydureon Bcise335
ByettaGLP-1 receptor agonist146
Byetta Pen Disposable26
Cabotegravir27
CelebrexNonsteroidal anti-inflammatory drug33
CellCeptAntimetabolite immunosuppressant48
ChantixPartial cholinergic nicotinic agonist68
Claritin122
CrestorHMG-CoA reductase inhibitor67
Diclofenac sodiumNonsteroidal anti-inflammatory drug192
DoxorubicinAnthracycline topoisomerase inhibitor39
DuleraCorticosteroid347
EligardGonadotropin releasing hormone receptor agonist138
EliquisFactor Xa inhibitor628
EnbrelTumor necrosis factor blocker2,126
EpclusaHepatitis C virus NS5A inhibitor53
Epidiolex33
EpinephrineCatecholamine29
EpogenErythropoiesis-stimulating agent537
ErbituxEpidermal growth factor receptor antagonist30
EstradiolEstrogen326
Evenity223
Excedrin MigraineCentral nervous system stimulant29
Fentora44
Follistim AQ34
GabapentinAnti-epileptic agent35
Genotropin134
Glatopa100
Hulio51
Human immunoglobulin gHuman immunoglobulin G31
Humira123
HyrimozTumor necrosis factor blocker146
IbranceKinase inhibitor58
IbuprofenNonsteroidal anti-inflammatory drug47
IlumyaInterleukin-23 antagonist36
IluvienCorticosteroid86
Imlygic87
Incruse ElliptaAnticholinergic25
InflectraTumor necrosis factor blocker42
JanumetBiguanide52
JanuviaDipeptidyl peptidase 4 inhibitor126
KanjintiHER2/neu receptor antagonist257
KesimptaCD20-directed cytolytic antibody37
KeytrudaProgrammed death Receptor-1 blocking antibody55
Krystexxa32
KyprolisProteasome inhibitor282
LantusInsulin analog25
Lantus SolostarInsulin analog73
LatanoprostProstaglandin analog37
LenalidomideThalidomide analog109
LipitorHMG-CoA reductase inhibitor30
LisinoprilAngiotensin converting enzyme inhibitor121
Lumakras26
Lyrica101
MethotrexateFolate analog metabolic inhibitor59
Metoprololbeta-Adrenergic blocker36
Metoprolol tartratebeta-Adrenergic blocker30
Miebo141
MiraLAXOsmotic laxative1,354
MvasiVascular endothelial growth factor inhibitor345
Myrbetriqbeta3-Adrenergic agonist78
NeulastaLeukocyte growth factor881
NeupogenLeukocyte growth factor253
NexiumProton pump inhibitor131
NexplanonProgestin241
NplateThrombopoietin receptor agonist236
NucalaInterleukin-5 antagonist62
NuvaringEstrogen43
OmeprazoleProton pump inhibitor77
OmnitropeRecombinant human growth hormone883
OpdivoProgrammed death Receptor-1 blocking antibody30
OrenciaSelective T cell costimulation modulator232
OtezlaPhosphodiesterase 4 inhibitor74
ParsabivCalcium-sensing receptor agonist82
Paxlovid162
PomalystThalidomide analog44
PrednisoneCorticosteroid32
Pregnyl40
ProcritErythropoiesis-stimulating agent52
ProliaRANK ligand inhibitor1,831
Proventil193
Pulmicort FlexhalerCorticosteroid324
Pulmozyme26
RepathaPCSK9 inhibitor2,870
RevlimidThalidomide analog116
RiabniCD20-directed cytolytic antibody116
RituxanCD20-directed cytolytic antibody32
RituximabCD20-directed cytolytic antibody94
SeroquelAtypical antipsychotic71
Sodium chlorideOsmotic laxative27
SprycelKinase inhibitor27
Sterile water25
SymbicortCorticosteroid771
Symbicort Pmdi33
Tanzeum70
Tepezza50
TestosteroneAndrogen66
Tice Bcg33
Travatan ZProstaglandin analog53
Trelegy ElliptaAnticholinergic95
TruvadaHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor44
Tudorza PressairAnticholinergic183
VectibixEpidermal growth factor receptor antagonist159
Ventolin Hfabeta2-Adrenergic agonist76
Vesicare28
ViagraPhosphodiesterase 5 inhibitor26
Voltaren Arthritis Pain95
XalatanProstaglandin analog45
Xcopri87
XeljanzJanus kinase inhibitor133
XgevaRANK ligand inhibitor288
Xiidra68
XolairAnti-IgE57
XtandiAndrogen receptor inhibitor125
YutiqCorticosteroid54
Zecuity30
ZenataneRetinoid56
ZoladexGonadotropin releasing hormone receptor agonist26

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 59 pharmacologic classes with 50 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 Circumstance or information capable of leading to medication error name, in order of name
ClassReports with this term
Androgen68
Androgen receptor inhibitor147
Angiotensin converting enzyme inhibitor129
Anti-epileptic agent89
Anti-IgE57
Anticholinergic558
Antimetabolite immunosuppressant59
Atypical antipsychotic241
B lymphocyte stimulator-specific inhibitor201
Benzodiazepine88
beta-Adrenergic blocker156
beta2-Adrenergic agonist437
beta3-Adrenergic agonist78
Biguanide87
Calcineurin inhibitor immunosuppressant63
Calcium-sensing receptor agonist103
Catecholamine66
CD20-directed cytolytic antibody185
Central nervous system stimulant85
Corticosteroid2,736
Dipeptidyl peptidase 4 inhibitor127
Epidermal growth factor receptor antagonist189
Erythropoiesis-stimulating agent1,642
Estrogen430
Factor Xa inhibitor670
Folate analog metabolic inhibitor75
GLP-1 receptor agonist176
Gonadotropin releasing hormone receptor agonist174
Hepatitis C virus NS5A inhibitor70
HER2/neu receptor antagonist297
HMG-CoA reductase inhibitor114
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor134
Human immunoglobulin G52
Insulin analog178
Interleukin-5 antagonist82
Janus kinase inhibitor137
Kinase inhibitor142
Leukocyte growth factor1,142
Nonsteroidal anti-inflammatory drug581
Opioid agonist85
Orexin receptor antagonist67
Osmotic laxative1,423
P2Y12 platelet inhibitor56
Partial cholinergic nicotinic agonist68
PCSK9 inhibitor2,870
Phosphodiesterase 4 inhibitor83
Progestin260
Programmed death Receptor-1 blocking antibody100
Prostaglandin analog164
Proteasome inhibitor284
Proton pump inhibitor286
RANK ligand inhibitor2,119
Recombinant human growth hormone883
Retinoid148
Selective T cell costimulation modulator246
Thalidomide analog271
Thrombopoietin receptor agonist238
Tumor necrosis factor blocker2,661
Vascular endothelial growth factor inhibitor389

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

Reports by month

Reports that record Circumstance or information capable of leading to medication error, 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 Circumstance or information capable of leading to medication error
AgeReportsShareShare as a bar
Under 2680.2%
2 to 113371%
12 to 173100.9%
18 to 441,1463.5%
45 to 642,7288.2%
65 to 742,2766.9%
75 and over2,1486.5%
Age not given24,09772.8%
Sex of the patient in the reports that record Circumstance or information capable of leading to medication error
SexReportsShareShare as a bar
Female11,47034.6%
Male6,84420.7%
Unknown or not given14,79644.7%

Age and sex are as the report gives them. 94.4% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Circumstance or information capable of leading to medication error: adverse event reports that record this term. https://reportedreactions.com/reaction/circumstance-or-information-capable-of-leading-to-medication-error/ 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 Circumstance or information capable of leading to medication error mean in an adverse event report?

In plain words: a situation that could lead to a medication error. 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 .