MedDRA preferred term · a dispensing mistake

Drug dispensing error: adverse event reports recording this term

15,289 reports to FDA record it, 2005–2018; 0.1% of the database.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

15,289
reports recording the term: 0.1% of all reports; 0
reports, 12 months to June 2026: 0 in the 12 months before; 28.9%
marked serious by the reporter: 57.4% across all reports; 1.7%
record death among outcomes, as reported: 9.1% across all reports

15,289 reports in FDA's adverse event database record the MedDRA term "Drug dispensing error" (in plain words, a dispensing mistake): 0.1% of all reports received between February 2005 and September 2018. Coders pick the term that best matches the reporter's description.

0 reports recorded it in the 12 months to June 2026, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 28.9% are marked serious, 1.7% include death among the outcomes and 11.6% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humalog, Humalog Mix75/25 and Anoro Ellipta. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Humalog	Insulin analog	1,126	1.6%
Humalog Mix75/25	Insulin analog	544	6.7%
Anoro Ellipta	Anticholinergic	496	4%
Breo Ellipta	Corticosteroid	412	1.9%
Humira	—	380	0.1%
Advair Diskus	Corticosteroid	215	1%
Enbrel	Tumor necrosis factor blocker	194	0%
Lyrica	—	194	0.2%
Seroquel	Atypical antipsychotic	163	0.3%
Cymbalta	Serotonin and norepinephrine reuptake inhibitor	153	0.3%
Humulin N	Insulin	144	1.3%
Lamictal	Anti-epileptic agent	139	0.4%
Tresiba Flextouch U200	—	134	7.4%
Humulin R	Insulin	124	1.5%
Tresiba	Insulin analog	121	1.2%
Humulin 70/30	Insulin	120	1.7%
Insulin lispro	Insulin analog	115	1.4%
Byetta	GLP-1 receptor agonist	105	0.2%
Ventolin Hfa	beta2-Adrenergic agonist	99	0.4%
Depakote	Anti-epileptic agent	92	0.6%
Eliquis	Factor Xa inhibitor	91	0.1%
Incruse Ellipta	Anticholinergic	90	2%
Chantix	Partial cholinergic nicotinic agonist	84	0.1%
Lamotrigine	Anti-epileptic agent	81	0.2%
Lipitor	HMG-CoA reductase inhibitor	76	0.1%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.1% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Insulin analog	2,083	0.7%	0.1%
Corticosteroid	927	0.1%	0%
Anticholinergic	712	0.4%	0%
Atypical antipsychotic	462	0.1%	0%
Anti-epileptic agent	442	0.2%	0%
Insulin	430	1.2%	0.6%
Opioid agonist	363	0%	0%
Tumor necrosis factor blocker	226	0%	0%
Serotonin and norepinephrine reuptake inhibitor	223	0.1%	0%
Serotonin reuptake inhibitor	209	0.1%	0.1%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 21.4%212

2 to 112.8%428

12 to 171.4%212

18 to 447.8%1,200

45 to 6414.6%2,225

65 to 747.3%1,109

75 and over6.8%1,038

Age not given58%8,865

Patient sex

Female47.7%7,295

Male31.8%4,866

Not given20.5%3,128

Grey bar: all 20,646,523 reports in the database. 87.4% of these reports give the United States as the country.

Questions about "Drug dispensing error"

What does "Drug dispensing error" mean in an adverse event report?

In plain language: a dispensing mistake. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record drug dispensing error?

15,289 reports through June 2026 (0.1% of all reports), 0 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humalog (1,126), Humalog Mix75/25 (544), Anoro Ellipta (496), Breo Ellipta (412) and Humira (380). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.