Feverall (acetaminophen) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Acetaminophen

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 2004 to June 2025, FDA received 540 adverse event reports that name Feverall. In these reports the drug is a suspect or interacting product.

In the same period, 5 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 0 reports in the 12 months to June 2026 and 7 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Reports from other health professionals were 55.4% of the reports that name Feverall and 19.7% 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 Feverall 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 0 reports that name Feverall.
In January to March 2026, FDA received 0.
In April to June 2025, FDA received 7.

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 84 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 502 of the 540 reports (93%).

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 84 terms.

Reaction terms in the reports that name Feverall, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 540 reports
Overdosea dose above the recommended amount	102	18.9%
Toxicity to various agentspoisoning or toxic effect of one or more substances	48	8.9%
Intentional overdosea deliberate overdose	39	7.2%
Vomitingbeing sick	39	7.2%
Accidental overdosean accidental overdose	37	6.9%
Hepatic necrosis	37	6.9%
Alanine aminotransferase increasedraised liver enzyme (ALT)	36	6.7%
Acute hepatic failure	33	6.1%
Cholestasis	31	5.7%
Aspartate aminotransferase increasedraised liver enzyme (AST)	30	5.6%
Hypotensionlow blood pressure	29	5.4%
International normalised ratio increasedblood clotting slower than intended (raised INR)	26	4.8%
Metabolic acidosistoo much acid in the body fluids	26	4.8%
Hepatocellular injury	24	4.4%
Nauseafeeling sick	23	4.3%
Hepatic failureliver failure	18	3.3%
Suicide attempta suicide attempt	18	3.3%
Drug ineffectivethe medicine did not work as expected	17	3.1%
Abdominal painstomach or belly pain	16	3%
Multiple drug overdose	15	2.8%
Liver injury	14	2.6%
Pyrexiafever	13	2.4%
Anaphylactic reactiona severe, sudden allergic reaction	12	2.2%
Coma	12	2.2%
Hepatotoxicityliver injury	12	2.2%
Prothrombin time prolonged	12	2.2%
Blood glucose increasedraised blood sugar reading	11	2%
Coagulopathy	11	2%
Encephalopathy	11	2%
Renal failurekidney failure	11	2%
Somnolencedrowsiness	11	2%
Stevens-Johnson syndromea severe skin and mucous-membrane reaction	11	2%
Agitationrestlessness	10	1.9%
Blood bilirubin increased	10	1.9%
Confusional stateconfusion	10	1.9%
Incorrect dose administeredthe wrong dose was given	10	1.9%
Multi-organ failure	10	1.9%
Multiple drug overdose intentional	10	1.9%
Unresponsive to stimuli	10	1.9%
Alcohol use	9	1.7%
Blood alkaline phosphatase increased	9	1.7%
Drug interactionan interaction between medicines	9	1.7%
Liver disorder	9	1.7%
Tachycardiafast heart rate	9	1.7%
Tachypnoea	9	1.7%
Urticariahives	9	1.7%
Diarrhoealoose or frequent stools	8	1.5%
Drug toxicity	8	1.5%
General physical health deteriorationgeneral decline in health	8	1.5%
Heart rate increaseda fast heart rate reading	8	1.5%

Download all 84 terms of Feverall (CSV)

The counts add to more than 540 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 Acetaminophen with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Acetaminophen	Generic name	86,936
Apap	Brand name	526
Childrens TYLENOL	Brand name	1,347
Feverall (this page)	Brand name	540
Infants TYLENOL	Brand name	769
Panadol	Brand name	712
TYLENOL Extra Strength	Brand name	7,851
Tylenol	Brand name	30,726
Tylenol 8 HR Arthritis Pain	Brand name	4,930
Tylenol 8HR	Brand name	1,124
Tylenol Pm Extra Strength	Brand name	221
Tylenol Regular Strength	Brand name	2,017

Sum of the separately reported names: 137,699. 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 Feverall, 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
2004	2	2	0	0	1	0	0	1	0
2006	4	4	1	0	2	0	0	2	0
2008	27	27	9	2	16	0	0	9	0
2009	110	110	9	8	77	3	0	65	0
2010	58	57	6	15	33	2	1	21	1
2011	129	129	25	19	87	4	0	83	0
2012	127	126	15	9	71	3	0	82	1
2013	23	23	2	0	17	0	0	4	0
2015	16	1	0	0	0	0	0	1	15
2016	10	0	0	0	0	0	0	0	10
2017	12	1	0	0	0	0	0	1	11
2018	2	0	0	0	0	0	0	0	2
2022	8	0	0	0	0	0	0	0	8
2023	2	0	0	0	0	0	0	0	2
2024	3	0	0	0	0	0	0	0	3
2025	7	0	0	0	0	0	0	0	7

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 Feverall, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Feverall, by the year in which FDA received them
Year	Reports
2004	2
2006	1
2008	30
2009	107
2010	60
2011	129
2012	130
2013	21
2015	16
2016	10
2017	12
2018	2
2022	8
2023	2
2024	3
2025	7

Reports that name Feverall, 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 Feverall
Age	Reports	Share
Under 2	58	10.7%
2 to 11	41	7.6%
12 to 17	30	5.6%
18 to 44	148	27.4%
45 to 64	75	13.9%
65 to 74	35	6.5%
75 and over	29	5.4%
Age not given	124	23%

Sex of the patient in the reports that name Feverall
Sex	Reports	Share
Female	256	47.4%
Male	216	40%
Unknown or not given	68	12.6%

Type of reporter in the reports that name Feverall
Reporter	Reports	Share
Physician	120	22.2%
Pharmacist	22	4.1%
Other health professional	299	55.4%
Lawyer	0	0%
Consumer or non-health professional	69	12.8%
Not given	30	5.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 27.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Feverall record
Indication as recorded (MedDRA)	Reports	Share
Pyrexia	37	6.9%
Pain	27	5%
Overdose	21	3.9%
Analgesic therapy	11	2%
Suicide attempt	8	1.5%
Intentional overdose	4	0.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 540 reports.

Pages near this one

Acetaminophen same ingredient
Apap same ingredient
Childrens TYLENOL same ingredient
Infants TYLENOL same ingredient
Panadol same ingredient
TYLENOL Extra Strength same ingredient
Fevarin next in the A to Z list
Fexofenadine next in the A to Z list
Fetzima next in the A to Z list
Fexofenadine hcl next in the A to Z list
Fetroja next in the A to Z list
Fexofenadine hydrochloride next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for FeverallThe 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. Feverall: adverse event reports that FDA received. https://reportedreactions.com/drug/feverall/ 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 Feverall as a suspect or interacting product. The 5 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 Feverall 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 Feverall?

No. It is a count of what people reported to FDA: 540 reports from May 2004 to June 2025. 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?

Other health professional (55.4%), physician (22.2%) and consumer or non-health professional (12.8%). 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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