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This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.

Extra Strength Acetaminophen Pm (acetaminophen 500mg)

Last updated: June 18, 2026
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Extra Strength Acetaminophen Pm is the brand name for acetaminophen 500mg. According to the FDA-approved label, temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness. FAERS contains 247,206 submissions naming this drug from 1998 through 2026; the top three reactions cited are off label use, fatigue, and drug ineffective.

Most-Reported Reactions

Counts of the reactions most often cited in FAERS submissions that named Extra Strength Acetaminophen Pm. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.

OFF LABEL USE 22,386 (9.1%) FATIGUE 20,445 (8.3%) DRUG INEFFECTIVE 18,158 (7.3%) PAIN 18,112 (7.3%) NAUSEA 17,644 (7.1%) HEADACHE 16,729 (6.8%) TOXICITY TO VARIOUS AGENTS 15,539 (6.3%) DYSPNOEA 14,589 (5.9%) ARTHRALGIA 14,311 (5.8%) PYREXIA 14,278 (5.8%) VOMITING 14,092 (5.7%) DIARRHOEA 13,393 (5.4%) RASH 12,436 (5.0%) INFUSION RELATED REACTION 10,997 (4.4%) PNEUMONIA 10,968 (4.4%)

Patient Demographics

Patient sex and age across the FAERS submissions that named Extra Strength Acetaminophen Pm. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.

By Sex

Female Male Unknown

By Age Group

0-17 18-44 45-64 65+

Severity Outcomes

Severity flags recorded across the 247,206 FAERS submissions that named Extra Strength Acetaminophen Pm. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.

DEATH 49,081 (19.9%) HOSPITALIZATION 111,215 (45.0%) LIFE-THREATENING 21,076 (8.5%) DISABLING 11,539 (4.7%)

Submissions Per Quarter

Quarterly count of FAERS submissions that named Extra Strength Acetaminophen Pm. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.

1998 1999 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026

From the FDA-Approved Label

Excerpts from the official FDA-approved prescribing information for Extra Strength Acetaminophen Pm. This is the authoritative source on indications, warnings, and known adverse reactions.

Indications

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

FDA label effective date: 2025-07-21

Disclaimer

AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.