MedDRA preferred term

Product administered to patient of inappropriate age: adverse event reports recording this term

5,930 reports to FDA record it, 2011–2026; 0% 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.

5,930
reports recording the term: 0% of all reports; 702
reports, 12 months to June 2026: 898 in the 12 months before; 33.4%
marked serious by the reporter: 57.4% across all reports; 3.3%
record death among outcomes, as reported: 9.1% across all reports

5,930 reports in FDA's adverse event database record the MedDRA term "Product administered to patient of inappropriate age": 0% of all reports received between July 2011 and June 2026. Coders pick the term that best matches the reporter's description.

702 reports recorded it in the 12 months to June 2026, down 22% from 898 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, 33.4% are marked serious, 3.3% include death among the outcomes and 14.5% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Hemangeol, Cetirizine hydrochloride and Propranolol. 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
Hemangeol	beta-Adrenergic blocker	657	15%
Cetirizine hydrochloride	Histamine-1 receptor antagonist	378	2%
Propranolol	beta-Adrenergic blocker	329	2.4%
Ibuprofen	Nonsteroidal anti-inflammatory drug	217	0.3%
Dupixent	Interleukin-4 receptor alpha antagonist	211	0%
Childrens Motrin	Nonsteroidal anti-inflammatory drug	199	10.3%
Propranolol hydrochloride	beta-Adrenergic blocker	167	2.7%
Childrens TYLENOL	Sigma-1 agonist	92	6.8%
Arikayce	Aminoglycoside antibacterial	91	1.4%
Polyethylene glycol 3350	Osmotic laxative	85	1.5%
Mycophenolate mofetil	Antimetabolite immunosuppressant	80	0.1%
Methotrexate	Folate analog metabolic inhibitor	79	0%
Fexofenadine	Histamine-1 receptor antagonist	75	2.4%
Tymlos	—	75	0.3%
Cyclophosphamide	Alkylating drug	74	0.1%
Dexmedetomidine hydrochloride	Central alpha-2 adrenergic agonist	72	5%
Epidiolex	—	72	0.4%
Sterile diluent	Insulin analog	69	2.1%
Motrin Infants	Nonsteroidal anti-inflammatory drug	66	12.6%
MiraLAX	Osmotic laxative	63	0.2%
Fludarabine phosphate	Nucleoside metabolic inhibitor	60	0.7%
Cyclosporine	Calcineurin inhibitor immunosuppressant	59	0.2%
Busulfan	Alkylating drug	58	0.5%
Flovent	Corticosteroid	56	0.5%
ProQuad	—	56	7.8%

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% 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
beta-Adrenergic blocker	1,158	0.8%	0%
Nonsteroidal anti-inflammatory drug	659	0.1%	0%
Histamine-1 receptor antagonist	502	0.4%	0%
Corticosteroid	309	0%	0%
Interleukin-4 receptor alpha antagonist	219	0%	0.1%
Atypical antipsychotic	215	0%	0%
Alkylating drug	200	0.1%	0%
Osmotic laxative	154	0.1%	0%
Serotonin reuptake inhibitor	128	0%	0%
Nucleoside metabolic inhibitor	125	0%	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 212.2%721

2 to 1119.3%1,142

12 to 1714.2%840

18 to 444%238

45 to 641.8%104

65 to 745.1%302

75 and over5.4%323

Age not given38.1%2,260

Patient sex

Female45.9%2,721

Male33.9%2,013

Not given20.2%1,196

Grey bar: all 20,646,523 reports in the database. 69.2% of these reports give the United States as the country.

Questions about "Product administered to patient of inappropriate age"

What does "Product administered to patient of inappropriate age" 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 administered to patient of inappropriate age?

5,930 reports through June 2026 (0% of all reports), 702 of them in the latest 12 months.

Which drugs appear most often in these reports?

Hemangeol (657), Cetirizine hydrochloride (378), Propranolol (329), Ibuprofen (217) and Dupixent (211). 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.