MedDRA preferred term

Product dose omission in error: adverse event reports recording this term

26,505 reports to FDA record it, 2013–2026; 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.

26,505
reports recording the term: 0.1% of all reports; 5,149
reports, 12 months to June 2026: 5,464 in the 12 months before; 25.3%
marked serious by the reporter: 57.4% across all reports; 0.6%
record death among outcomes, as reported: 9.1% across all reports

26,505 reports in FDA's adverse event database record the MedDRA term "Product dose omission in error": 0.1% of all reports received between January 2013 and June 2026. Coders pick the term that best matches the reporter's description.

5,149 reports recorded it in the 12 months to June 2026, close to the 5,464 of 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, 25.3% are marked serious, 0.6% include death among the outcomes and 9.6% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Dupixent, Xeljanz and Tymlos. 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
Dupixent	Interleukin-4 receptor alpha antagonist	9,643	2.1%
Xeljanz	Janus kinase inhibitor	2,558	1.6%
Tymlos	—	629	2.2%
Ibrance	Kinase inhibitor	616	0.8%
Vumerity	—	507	4.4%
Jakafi	Janus kinase inhibitor	450	0.8%
Revlimid	Thalidomide analog	392	0.1%
Lenalidomide	Thalidomide analog	338	0.5%
Aubagio	Pyrimidine synthesis inhibitor	328	0.9%
Orgovyx	Gonadotropin releasing hormone receptor antagonist	306	1.4%
Tecfidera	—	303	0.3%
Entresto	Angiotensin 2 receptor blocker	280	0.3%
Nuplazid	Atypical antipsychotic	254	0.5%
Niraparib	Poly(ADP-Ribose) polymerase inhibitor	228	3.5%
Dovato	Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	223	7.3%
Zejula	Poly(ADP-Ribose) polymerase inhibitor	199	1.3%
Lupkynis	Calcineurin inhibitor immunosuppressant	170	2%
Pomalyst	Thalidomide analog	170	0.2%
Eliquis	Factor Xa inhibitor	168	0.1%
Ayvakit	Kinase inhibitor	158	1.4%
Kevzara	Interleukin-6 receptor antagonist	158	0.7%
Esbriet	Pyridone	156	0.4%
Cimzia	Tumor necrosis factor blocker	155	0.2%
Cerdelga	—	148	10.2%
Haegarda	—	133	2.8%

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
Interleukin-4 receptor alpha antagonist	9,760	2.1%	1.5%
Janus kinase inhibitor	3,079	1%	0%
Kinase inhibitor	1,447	0.2%	0%
Thalidomide analog	900	0.2%	0.2%
Poly(ADP-Ribose) polymerase inhibitor	574	1.1%	0.3%
Tumor necrosis factor blocker	438	0%	0%
Pyrimidine synthesis inhibitor	368	0.9%	0.9%
Atypical antipsychotic	347	0.1%	0%
Gonadotropin releasing hormone receptor antagonist	306	1.1%	0%
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	305	0.4%	0%

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 20.2%45

2 to 112.1%568

12 to 173.2%839

18 to 4420.1%5,324

45 to 6424.5%6,504

65 to 7411.4%3,028

75 and over8.2%2,181

Age not given30.2%8,016

Patient sex

Female60%15,915

Male32.4%8,580

Not given7.6%2,010

Grey bar: all 20,646,523 reports in the database. 93.7% of these reports give the United States as the country.

Questions about "Product dose omission in error"

What does "Product dose omission in error" mean in an adverse event report?

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 product dose omission in error?

26,505 reports through June 2026 (0.1% of all reports), 5,149 of them in the latest 12 months.

Which drugs appear most often in these reports?

Dupixent (9,643), Xeljanz (2,558), Tymlos (629), Ibrance (616) and Vumerity (507). 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.