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.

Acetaminophen (acetaminophen tablet extended release)

Last updated: June 18, 2026

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Acetaminophen is the brand name for acetaminophen tablet extended release. According to the FDA-approved label, For Arthritis Pain temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever For Muscle Aches & Pains temporarily relieves minor aches and pains. FAERS contains 246,995 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 Acetaminophen. 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.

Patient Demographics

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

By Sex

By Age Group

Severity Outcomes

Severity flags recorded across the 246,995 FAERS submissions that named Acetaminophen. 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.

Submissions Per Quarter

Quarterly count of FAERS submissions that named Acetaminophen. 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.

From the FDA-Approved Label

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

Indications

For Arthritis Pain temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever For Muscle Aches & Pains temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount 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: 2025-02-24

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.