Infants Tylenolacetaminophen
According to the FDA label: Uses temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
247,830 adverse event reports submitted to the FDA (1998–2026)
Top Reported Adverse Events
The most frequently reported events in association with Infants Tylenol in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Off Label Use 22,455 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Fatigue 20,439 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 18,192 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Pain 18,106 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Nausea 17,629 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Headache 16,713 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Toxicity to Various Agents 15,539 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Dyspnoea 14,585 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Arthralgia 14,308 reports
Pyrexia 14,288 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Vomiting 14,140 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 13,402 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Rash 12,440 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Infusion Related Reaction 10,964 reports
A reaction that happens during or shortly after a medication is given through an IV infusion.
Full definition in the glossary →Pneumonia 10,964 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 135,069 |
| Male | 81,649 |
| Unknown | 513 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 14,280 |
| 18-34 | 21,193 |
| 35-49 | 31,896 |
| 50-64 | 43,580 |
| 65-74 | 32,802 |
| 75+ | 32,052 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Infants Tylenol. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 132,562 |
| Hospitalization | 111,212 |
| Death | 49,067 |
| Non-Serious | 31,838 |
| Life-Threatening | 21,071 |
| Disability | 11,534 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Infants Tylenol. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1998 | 1 |
| 1999 | 4 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 4 |
| 2004 | 2,586 |
| 2005 | 2,680 |
| 2006 | 3,146 |
| 2007 | 2,543 |
| 2008 | 3,848 |
| 2009 | 2,965 |
| 2010 | 3,788 |
| 2011 | 8,050 |
| 2012 | 8,036 |
| 2013 | 3,371 |
| 2014 | 4,026 |
| 2015 | 6,297 |
| 2016 | 8,446 |
| 2017 | 7,600 |
| 2018 | 9,238 |
| 2019 | 12,646 |
| 2020 | 19,742 |
| 2021 | 19,978 |
| 2022 | 27,166 |
| 2023 | 27,938 |
| 2024 | 28,597 |
| 2025 | 28,085 |
| 2026 (partial) | 7,047 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Infants Tylenol
In FDA adverse event reports that mention Infants Tylenol, these medications appeared most often in the same report.
- Diphenhydramine (48,788 reports)
- Prednisone (34,943 reports)
- Pantoprazole (28,734 reports)
- Ibuprofen (28,012 reports)
- Aspirin (27,855 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026