Childrens Advil (ibuprofen) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Childrens Advil
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Ibuprofen
Class: Nonsteroidal anti-inflammatory drug

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.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From May 2012 to April 2026, FDA received 735 adverse event reports that name Childrens Advil. In these reports the drug is a suspect or interacting product.

In the same period, 39 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 4 reports in the 12 months to June 2026 and 13 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 4 (under 0.1%) name Childrens Advil. Reports from consumers or other non-health professionals were 90.5% of the reports that name Childrens Advil and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
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.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Childrens Advil is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

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

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
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.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 2 reports that name Childrens Advil.
In January to March 2026, FDA received 0.
In April to June 2025, FDA received 0.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 60 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 715 of the 735 reports (97.3%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 60 terms.

Reaction terms in the reports that name Childrens Advil, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 735 reports
Drug ineffectivethe medicine did not work as expected	144	19.6%
Vomitingbeing sick	75	10.2%
Hypersensitivityan allergic-type reaction	45	6.1%
Poor quality drug administered	43	5.9%
Product quality issuea problem with the product itself	43	5.9%
Drug administered to patient of inappropriate age	40	5.4%
Product taste abnormalthe product tasted odd	32	4.4%
Rashskin rash	32	4.4%
Urticariahives	30	4.1%
Drug administration errora mistake in giving the medicine	29	3.9%
Drug effect incomplete	28	3.8%
Throat irritationan irritated throat	27	3.7%
Product use issuea problem in how the product was used	24	3.3%
Dysgeusiaaltered taste	20	2.7%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	19	2.6%
Condition aggravatedthe condition being treated got worse	18	2.4%
Eye swellinga swollen eye	18	2.4%
Malaisegeneral feeling of being unwell	18	2.4%
Somnolencedrowsiness	18	2.4%
Abdominal pain upperupper stomach pain	17	2.3%
Pyrexiafever	17	2.3%
Intentional product misusedeliberate use not as intended	16	2.2%
Therapeutic response unexpected	16	2.2%
Seizurea fit or convulsion	15	2%
Lip swellingswollen lips	14	1.9%
Cough	13	1.8%
Erythemaskin redness	13	1.8%
Glossodynia	13	1.8%
Product use in unapproved indicationused for a purpose not on the label	12	1.6%
Pruritusitching	12	1.6%
Abdominal discomfortstomach discomfort	11	1.5%
Discomfort	11	1.5%
Retching	11	1.5%
Swelling facea swollen face	11	1.5%
Pneumonialung infection	9	1.2%
Pre-existing condition improved	9	1.2%
Feeling abnormalfeeling odd or not right	8	1.1%
Dysphagiadifficulty swallowing	7	1%
Dyspnoeashortness of breath	7	1%
Fatiguetiredness	7	1%
Febrile convulsion	7	1%
Hallucinationseeing or hearing things that are not there	7	1%
Headachehead pain	7	1%
Accidental exposure to product by child	6	0.8%
Anxiety	6	0.8%
Blistera blister	6	0.8%
Diarrhoealoose or frequent stools	6	0.8%
Dizzinesslight-headedness or unsteadiness	6	0.8%
Nauseafeeling sick	6	0.8%
Blood glucose increasedraised blood sugar reading	5	0.7%

Download all 60 terms of Childrens Advil (CSV)

The counts add to more than 735 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. 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.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Ibuprofen with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Ibuprofen	Generic name	77,058
Ibuprofen tablets	Generic name	690
Advil	Brand name	19,649
Advil Liqui-Gels	Brand name	2,635
Advil Migraine	Brand name	556
Childrens Advil (this page)	Brand name	735
Childrens Ibuprofen	Brand name	375
Childrens MOTRIN	Brand name	1,927
Junior Strength Advil	Brand name	232
Motrin	Brand name	4,658
Motrin IB	Brand name	1,494
Motrin IB Migraine	Brand name	293
Motrin Infants	Brand name	524

Sum of the separately reported names: 110,826. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Childrens Advil, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2012	35	5	0	0	0	0	0	5	30
2013	106	11	0	0	4	0	0	7	95
2014	82	11	1	1	10	0	0	4	71
2015	132	14	1	3	6	1	0	9	118
2016	162	48	1	1	14	0	0	41	114
2017	58	11	0	0	7	0	0	9	47
2018	46	20	0	2	6	0	0	15	26
2019	23	10	0	0	2	0	0	9	13
2020	12	5	0	0	1	0	0	4	7
2021	21	2	0	0	0	0	0	2	19
2022	8	3	0	0	1	0	0	3	5
2023	20	3	0	1	1	1	0	3	17
2024	18	9	5	5	5	5	0	9	9
2025	8	6	5	5	5	5	1	6	2
2026	4	2	1	2	1	1	1	2	2

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

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.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Childrens Advil, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Childrens Advil, by the year in which FDA received them
Year	Reports
2012	39
2013	107
2014	82
2015	138
2016	161
2017	51
2018	44
2019	23
2020	11
2021	21
2022	8
2023	25
2024	18
2025	5
2026	2

Reports that name Childrens Advil, 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.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Childrens Advil
Age	Reports	Share
Under 2	34	4.6%
2 to 11	235	32%
12 to 17	21	2.9%
18 to 44	21	2.9%
45 to 64	22	3%
65 to 74	6	0.8%
75 and over	5	0.7%
Age not given	391	53.2%

Sex of the patient in the reports that name Childrens Advil
Sex	Reports	Share
Female	299	40.7%
Male	254	34.6%
Unknown or not given	182	24.8%

Type of reporter in the reports that name Childrens Advil
Reporter	Reports	Share
Physician	24	3.3%
Pharmacist	4	0.5%
Other health professional	40	5.4%
Lawyer	1	0.1%
Consumer or non-health professional	665	90.5%
Not given	1	0.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 85.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Childrens Advil record
Indication as recorded (MedDRA)	Reports	Share
Pyrexia	171	23.3%
Nasopharyngitis	32	4.4%
Pain	31	4.2%
Headache	21	2.9%
Cough	13	1.8%
Antipyresis	5	0.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 735 reports.

Pages near this one

Ibuprofen same ingredient
Ibuprofen tablets same ingredient
Advil same ingredient
Advil Liqui-Gels same ingredient
Advil Migraine same ingredient
Childrens Ibuprofen same ingredient
Celecoxib same class
Celebrex same class
Childrens MOTRIN same class
Cambia same class
Diclofenac same class
Children's Tylenol Suspension next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Childrens AdvilThe labels (prescribing information) that have this name, at the National Library of Medicine.
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. Childrens Advil: adverse event reports that FDA received. https://reportedreactions.com/drug/childrens-advil/ 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.

A report is in the count when it names Childrens Advil as a suspect or interacting product. The 39 reports that name it only as a concomitant medicine are not in the count. 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

Do these reports show that Childrens Advil was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
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.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Childrens Advil?

No. It is a count of what people reported to FDA: 735 reports from May 2012 to April 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (90.5%), other health professional (5.4%) and physician (3.3%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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