Advil pm adverse event reports that FDA received

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

Name type: Generic name
Class: Nonsteroidal anti-inflammatory drug
Also reported as: Advil Pm /05810501/, Advil Pm Nos

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 July 2006 to May 2026, FDA received 4,978 adverse event reports that name Advil pm. In these reports the drug is a suspect or interacting product.

In the same period, 557 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 134 reports in the 12 months to June 2026 and 199 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, 134 (under 0.1%) name Advil pm. Reports from consumers or other non-health professionals were 93.9% of the reports that name Advil pm 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 Advil pm 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 Advil pm.
In January to March 2026, FDA received 9.
In April to June 2025, FDA received 123.

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 163 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 4,963 of the 4,978 reports (99.7%).

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 163 terms.

Reaction terms in the reports that name Advil pm, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,978 reports
Drug ineffectivethe medicine did not work as expected	1,188	23.9%
Product use in unapproved indicationused for a purpose not on the label	964	19.4%
Drug effective for unapproved indication	862	17.3%
Somnolencedrowsiness	581	11.7%
Insomniadifficulty sleeping	215	4.3%
Feeling abnormalfeeling odd or not right	198	4%
Dizzinesslight-headedness or unsteadiness	148	3%
Intentional product misusedeliberate use not as intended	138	2.8%
Fatiguetiredness	133	2.7%
Overdosea dose above the recommended amount	108	2.2%
Incorrect dose administeredthe wrong dose was given	107	2.1%
Drug effect incomplete	96	1.9%
Malaisegeneral feeling of being unwell	91	1.8%
Headachehead pain	90	1.8%
Therapeutic product effect incomplete	86	1.7%
Dysphagiadifficulty swallowing	80	1.6%
Restlessness	80	1.6%
Drug effect decreasedthe medicine had less effect	78	1.6%
Therapeutic response unexpected	65	1.3%
Nauseafeeling sick	64	1.3%
Abdominal discomfortstomach discomfort	63	1.3%
Condition aggravatedthe condition being treated got worse	62	1.2%
Product use issuea problem in how the product was used	61	1.2%
Restless legs syndrome	59	1.2%
Drug ineffective for unapproved indication	55	1.1%
Abdominal pain upperupper stomach pain	54	1.1%
Intentional product use issuedeliberate use not as intended	52	1%
Nightmarenightmares	49	1%
Feeling jittery	47	0.9%
Painpain, site not specified	47	0.9%
Poor quality sleep	46	0.9%
Vomitingbeing sick	45	0.9%
Foreign bodyan object where it should not be	43	0.9%
Tremorshaking	42	0.8%
Wrong drug administeredthe wrong medicine was given	42	0.8%
Middle insomnia	41	0.8%
Expired product administeredthe product was used past its expiry date	40	0.8%
Dyspnoeashortness of breath	39	0.8%
Drug effect less than expected	38	0.8%
Hangover	38	0.8%
Poor quality drug administered	38	0.8%
Wrong technique in product usage processthe product was used in the wrong way	38	0.8%
Anxiety	37	0.7%
Dry mouth	37	0.7%
Sleep disordera sleep problem	37	0.7%
Nervousness	36	0.7%
Product physical issuea physical defect in the product	34	0.7%
Product size issue	34	0.7%
Diarrhoealoose or frequent stools	33	0.7%
Abnormal dreamsunusual dreams	32	0.6%

Download all 163 terms of Advil pm (CSV)

The counts add to more than 4,978 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.

Outcomes by year

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

Outcomes in the reports that name Advil pm, 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	Other Serious (Important Medical Events)	Not serious
2006	117	112	0	0	1	0	112	5
2007	47	46	1	0	4	0	42	1
2008	54	50	1	0	1	0	48	4
2009	126	12	0	0	1	0	12	114
2010	265	18	0	0	2	0	16	247
2011	216	31	0	1	8	0	25	185
2012	194	23	2	0	2	0	20	171
2013	315	35	0	0	4	0	31	280
2014	281	17	0	1	2	1	14	264
2015	362	33	0	0	13	0	23	329
2016	411	34	2	0	8	1	30	377
2017	231	26	0	0	6	0	23	205
2018	355	26	2	0	12	1	20	329
2019	126	21	0	0	6	0	17	105
2020	159	28	0	0	6	1	23	131
2021	532	21	0	0	1	0	21	511
2022	122	2	0	0	0	0	2	120
2023	85	5	0	0	0	0	5	80
2024	665	10	0	0	5	0	10	655
2025	304	3	0	0	1	0	3	301
2026	11	0	0	0	0	0	0	11

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 Advil pm, 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 Advil pm, by the year in which FDA received them
Year	Reports
2006	38
2007	125
2008	46
2009	18
2010	371
2011	223
2012	238
2013	281
2014	291
2015	359
2016	418
2017	233
2018	345
2019	126
2020	150
2021	531
2022	122
2023	83
2024	665
2025	304
2026	11

Reports that name Advil pm, 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 Advil pm
Age	Reports	Share
Under 2	2	under 0.1%
2 to 11	6	0.1%
12 to 17	10	0.2%
18 to 44	331	6.6%
45 to 64	517	10.4%
65 to 74	315	6.3%
75 and over	435	8.7%
Age not given	3,362	67.5%

Sex of the patient in the reports that name Advil pm
Sex	Reports	Share
Female	2,137	42.9%
Male	964	19.4%
Unknown or not given	1,877	37.7%

Type of reporter in the reports that name Advil pm
Reporter	Reports	Share
Physician	46	0.9%
Pharmacist	11	0.2%
Other health professional	45	0.9%
Lawyer	3	0.1%
Consumer or non-health professional	4,675	93.9%
Not given	198	4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 99.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Advil pm record
Indication as recorded (MedDRA)	Reports	Share
Insomnia	859	17.3%
Sleep disorder	580	11.7%
Pain	530	10.6%
Headache	245	4.9%
Migraine	227	4.6%
Back pain	148	3%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,978 reports.

Drugs in the same reports

Other drugs that the reports of Advil pm name, in any role, in order of name
Drug	Reports that name the two
Advil	180
Advil Liqui-Gels	27
Aspirin	33
Ibuprofen	40
Levothyroxine	32
Lipitor	45
Lisinopril	54
Metformin	25
Simvastatin	24
Synthroid	46

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

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.

Pages near this one

Advil Migraine same class
Advil Sinus Congestion And Pain same class
Advil Liqui-Gels same class
Aleve same class
Advil Dual Action with Acetaminophen Back Pain same class
Aleve Back and Muscle Pain same class
Adynovate next in the A to Z list
Advil Liqui Gels next in the A to Z list
Adzenys XR-ODT next in the A to Z list
Aerius next in the A to Z list
Advil Dual Action With Acetaminophen next in the A to Z list
Aerolin 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 Advil pmThe 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. Advil pm: adverse event reports that FDA received. https://reportedreactions.com/drug/advil-pm/ 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 Advil pm as a suspect or interacting product. The 557 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 Advil pm 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 Advil pm?

No. It is a count of what people reported to FDA: 4,978 reports from July 2006 to May 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 (93.9%), physician (0.9%) and other health professional (0.9%). 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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