MedDRA preferred term · a dose was missed

Product dose omission: adverse event reports recording this term

65,353 reports to FDA record it, 2009–2020; 0.3% 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.

65,353
reports recording the term: 0.3% of all reports; 0
reports, 12 months to June 2026: 0 in the 12 months before; 24.5%
marked serious by the reporter: 57.4% across all reports; 1.4%
record death among outcomes, as reported: 9.1% across all reports

"Product dose omission" (in plain words, a dose was missed) is a MedDRA preferred term recorded in 65,353 adverse event reports received by FDA, 0.3% of the database, from December 2009 to June 2020. The term is chosen by whoever codes the report to match what the reporter described.

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, 24.5% are marked serious, 1.4% include death among the outcomes and 13.5% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Otezla, Dupixent and Stelara. 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
Otezla	Phosphodiesterase 4 inhibitor	4,542	3.3%
Dupixent	Interleukin-4 receptor alpha antagonist	2,450	0.5%
Stelara	Interleukin-12 antagonist	1,646	1.9%
Enbrel	Tumor necrosis factor blocker	1,396	0.2%
Revlimid	Thalidomide analog	1,369	0.4%
Jakafi	Janus kinase inhibitor	1,368	2.5%
Praluent	PCSK9 inhibitor	1,270	5.7%
Tecfidera	—	1,247	1.1%
Xeljanz	Janus kinase inhibitor	1,110	0.7%
Cosentyx	Interleukin-17A antagonist	929	0.6%
Opsumit	Endothelin receptor antagonist	902	2.2%
Cimzia	Tumor necrosis factor blocker	884	1%
Aubagio	Pyrimidine synthesis inhibitor	757	2%
Ampyra	Potassium channel blocker	715	1.3%
Symbicort	Corticosteroid	684	1.7%
Simponi	Tumor necrosis factor blocker	673	1%
Gilenya	Sphingosine 1-phosphate receptor modulator	658	0.8%
Trulicity	GLP-1 receptor agonist	647	0.9%
Benlysta	B lymphocyte stimulator-specific inhibitor	636	2.4%
Repatha	PCSK9 inhibitor	635	0.4%
Makena	—	608	2.7%
Ventolin Hfa	beta2-Adrenergic agonist	594	2.6%
Genotropin	—	589	1.3%
Tremfya	Interleukin-23 antagonist	567	1.8%
Breo Ellipta	Corticosteroid	554	2.5%

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 0.3% 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
Phosphodiesterase 4 inhibitor	4,600	3%	0.5%
Corticosteroid	3,677	0.5%	0%
Tumor necrosis factor blocker	3,568	0.3%	0%
Interleukin-4 receptor alpha antagonist	2,728	0.6%	1.4%
Janus kinase inhibitor	2,488	0.8%	0%
Insulin analog	2,281	0.8%	0.4%
PCSK9 inhibitor	1,991	1.1%	3.1%
Atypical antipsychotic	1,756	0.3%	0.1%
Thalidomide analog	1,733	0.3%	0.3%
Endothelin receptor antagonist	1,655	0.9%	0.7%

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 20.1%93

2 to 111.1%701

12 to 171.4%912

18 to 4412.9%8,449

45 to 6422%14,389

65 to 7410.1%6,621

75 and over7.2%4,734

Age not given45.1%29,454

Patient sex

Female59%38,589

Male32.3%21,134

Not given8.6%5,630

Grey bar: all 20,646,523 reports in the database. 94.3% of these reports give the United States as the country.

Questions about "Product dose omission"

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

In plain language: a dose was missed. 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?

65,353 reports through June 2026 (0.3% of all reports), 0 of them in the latest 12 months.

Which drugs appear most often in these reports?

Otezla (4,542), Dupixent (2,450), Stelara (1,646), Enbrel (1,396) and Revlimid (1,369). 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.