Drug administered to patient of inappropriate age adverse event reports that record this term

Kind of term: MedDRA preferred term

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 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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 January 2009 to September 2018, FDA received 7,173 adverse event reports that record the MedDRA preferred term Drug administered to patient of inappropriate age. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 0 reports in the 12 months to June 2026 and 0 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Reports for patients aged 2 to 11 were 30.3% of the reports that record this term and 1.4% 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.

Data version

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

Drugs in these reports

The table has the 128 drug pages with 10 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Drug administered to patient of inappropriate age name as a suspect product, in order of name
Drug	Class	Reports with this term
Abilify	Atypical antipsychotic	93
Abilify Maintena		12
Abreva	Non-Standardized chemical allergen	12
Acarizax		18
Acetaminophen		11
Adderall	Central nervous system stimulant	12
Advair Hfa	Corticosteroid	85
Advil	Nonsteroidal anti-inflammatory drug	22
Aerolin		18
Aleve	Nonsteroidal anti-inflammatory drug	32
Allegra		32
Ambrisentan	Endothelin receptor antagonist	14
Aripiprazole	Atypical antipsychotic	31
Aspirin	Nonsteroidal anti-inflammatory drug	22
Avonex	Interferon beta	79
Azithromycin Anhydrous		14
Bacteriostatic sodium chloride		26
Bayer aspirin extra strength	Nonsteroidal anti-inflammatory drug	10
Bayer genuine aspirin	Nonsteroidal anti-inflammatory drug	13
Breo Ellipta	Corticosteroid	35
Budesonide	Corticosteroid	12
Cambia	Nonsteroidal anti-inflammatory drug	91
Cetirizine hydrochloride	Histamine-1 receptor antagonist	313
Childrens Advil	Nonsteroidal anti-inflammatory drug	40
Childrens MOTRIN	Nonsteroidal anti-inflammatory drug	112
Childrens TYLENOL	Sigma-1 agonist	131
Childrens Zyrtec	Histamine-1 receptor antagonist	12
Ciclosporin		17
Claritin		105
Claritin Reditabs		12
Clozaril	Atypical antipsychotic	11
Cyclophosphamide	Alkylating drug	11
Delsym	Expectorant	78
Depakene		25
Depakote	Anti-epileptic agent	24
Dexmedetomidine hydrochloride	Central alpha-2 adrenergic agonist	36
Diazepam	Benzodiazepine	12
Divalproex sodium er	Anti-epileptic agent	10
Dulera	Corticosteroid	83
Dupixent	Interleukin-4 receptor alpha antagonist	31
Entyvio	Integrin receptor antagonist	82
Envarsus	Calcineurin inhibitor immunosuppressant	10
Etoposide	Topoisomerase inhibitor	15
Eucrisa	Phosphodiesterase 4 inhibitor	44
Excedrin	Central nervous system stimulant	12
Excedrin Migraine	Central nervous system stimulant	17
Fanapt	Atypical antipsychotic	11
Fentanyl	Opioid agonist	13
Fexofenadine	Histamine-1 receptor antagonist	208
Firazyr	Bradykinin B2 receptor antagonist	11
Flixotide		22
Flonase Allergy Relief		10
Flovent	Corticosteroid	65
Flovent Diskus		45
Fycompa	Noncompetitive AMPA glutamate receptor antagonist	15
Gilenya	Sphingosine 1-phosphate receptor modulator	90
Hemangeol	beta-Adrenergic blocker	66
Humira		11
Ibuprofen	Nonsteroidal anti-inflammatory drug	65
Infants TYLENOL		37
Intuniv	Central alpha-2 adrenergic agonist	21
Jakafi	Janus kinase inhibitor	25
Junior Strength Advil	Nonsteroidal anti-inflammatory drug	14
Juxtapid		32
Levetiracetam		26
Lialda	Aminosalicylate	52
Lyrica		14
M-M-R Ii		10
Methylphenidate hydrochloride	Central nervous system stimulant	13
Methylprednisolone	Corticosteroid	17
Midazolam	Benzodiazepine	16
MiraLAX	Osmotic laxative	973
Motrin	Nonsteroidal anti-inflammatory drug	28
Motrin Infants	Nonsteroidal anti-inflammatory drug	23
Mycophenolate mofetil	Antimetabolite immunosuppressant	10
Nexplanon	Progestin	26
Noxafil	Azole antifungal	10
Nuedexta	Antiarrhythmic	13
Octreotide	Somatostatin analog	12
Onzetra		10
Oxycodone hydrochloride	Opioid agonist	12
Pentasa	Aminosalicylate	31
Plegridy	Interferon beta	21
Polyethylene glycol 3350	Osmotic laxative	42
Prednisone	Corticosteroid	12
Prevacid	Proton pump inhibitor	18
Prevacid 24 HR	Proton pump inhibitor	24
Prevacid SoluTab	Proton pump inhibitor	27
Proactiv Solution Daily Protection Plus Sunscreen Spf 30		93
Proair Hfa		14
Procysbi		10
Propofol	General anesthetic	18
Propranolol	beta-Adrenergic blocker	46
Propranolol hydrochloride	beta-Adrenergic blocker	13
ProQuad		26
Pulmicort Flexhaler	Corticosteroid	12
Pulmicort Respules	Corticosteroid	22
Quillivant	Central nervous system stimulant	16
Qvar		70
Qvar Redihaler	Corticosteroid	14
Revatio	Phosphodiesterase 5 inhibitor	16
Rexulti	Atypical antipsychotic	121
Risperdal	Atypical antipsychotic	21
Risperidone	Atypical antipsychotic	18
Ritalin	Central nervous system stimulant	23
Saphris	Atypical antipsychotic	21
Seretide		25
Seroquel	Atypical antipsychotic	11
Soliris	Complement inhibitor	16
Sprix		11
Sprycel	Kinase inhibitor	26
Sterile diluent	Insulin analog	33
Symbicort	Corticosteroid	21
Tecfidera		86
Temodar	Alkylating drug	11
Tobi	Aminoglycoside antibacterial	99
Topiramate		39
Tracleer	Endothelin receptor antagonist	30
Transderm Scop	Anticholinergic	26
Tretinoin	Retinoid	19
Trintellix		18
Tysabri	Integrin receptor antagonist	71
Vedolizumab	Integrin receptor antagonist	22
Ventavis		14
Ventolin Hfa	beta2-Adrenergic agonist	42
Vyvanse	Central nervous system stimulant	52
Zecuity		12
Zyrtec	Histamine-1 receptor antagonist	18

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 52 pharmacologic classes with 10 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Drug administered to patient of inappropriate age name, in order of name
Class	Reports with this term
Alkylating drug	35
Aminoglycoside antibacterial	114
Aminosalicylate	85
Anti-epileptic agent	78
Antiarrhythmic	15
Anticholinergic	35
Antimetabolite	12
Antimetabolite immunosuppressant	13
Atypical antipsychotic	372
Azole antifungal	16
Benzodiazepine	55
beta-Adrenergic blocker	139
beta2-Adrenergic agonist	53
Bradykinin B2 receptor antagonist	11
Calcineurin inhibitor immunosuppressant	22
Central alpha-2 adrenergic agonist	69
Central nervous system stimulant	163
Complement inhibitor	16
Corticosteroid	445
Endothelin receptor antagonist	50
Expectorant	96
Folate analog metabolic inhibitor	14
General anesthetic	30
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	12
Histamine-1 receptor antagonist	573
Insulin analog	35
Integrin receptor antagonist	175
Interferon beta	100
Interleukin-4 receptor alpha antagonist	31
Janus kinase inhibitor	37
Kinase inhibitor	86
Leukotriene receptor antagonist	13
Loop diuretic	14
Non-Standardized chemical allergen	12
Noncompetitive AMPA glutamate receptor antagonist	15
Nonsteroidal anti-inflammatory drug	479
Opioid agonist	50
Osmotic laxative	1,017
Phosphodiesterase 4 inhibitor	44
Phosphodiesterase 5 inhibitor	31
Progestin	30
Proton pump inhibitor	57
Retinoid	21
Serotonin and norepinephrine reuptake inhibitor	10
Serotonin reuptake inhibitor	30
Sigma-1 agonist	131
Somatostatin analog	12
Sphingosine 1-phosphate receptor modulator	90
Thrombopoietin receptor agonist	10
Topoisomerase inhibitor	21
Tumor necrosis factor blocker	12
Vitamin K antagonist	17

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

Reports by month

Reports that record Drug administered to patient of inappropriate age, by month, five years to June 2026

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 Drug administered to patient of inappropriate age
Age	Reports	Share
Under 2	816	11.4%
2 to 11	2,174	30.3%
12 to 17	1,241	17.3%
18 to 44	193	2.7%
45 to 64	97	1.4%
65 to 74	331	4.6%
75 and over	359	5%
Age not given	1,962	27.4%

Sex of the patient in the reports that record Drug administered to patient of inappropriate age
Sex	Reports	Share
Female	3,439	47.9%
Male	2,749	38.3%
Unknown or not given	985	13.7%

Age and sex are as the report gives them. 84.2% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Drug administered to patient of inappropriate age: adverse event reports that record this term. https://reportedreactions.com/reaction/drug-administered-to-patient-of-inappropriate-age/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

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 Drug administered to patient of inappropriate age mean in an adverse event report?

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 2 Oct 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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