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Analgesic / antipyretic · Brand: Pain Relief, Heb + 32 more

Acetaminophen Side Effects: Common, Serious & FDA Warnings

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FDA-Approved For
Quick answer

Based on 884,000+ FDA adverse event reports, the most-reported acetaminophen reactions include pain, fatigue, and nausea. No active recalls are on record. The FDA-approved label does not carry a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

Common Side Effects of Acetaminophen

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for acetaminophen. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

ReactionReports% of total
Pain60,3596.8%
Fatigue56,0236.3%
Nausea53,3926.0%
Headache48,5735.5%
Overdose44,0275.0%
Diarrhoea39,4904.5%
Dyspnoea38,0734.3%
Vomiting35,9834.1%
Arthralgia34,8923.9%
Dizziness31,9053.6%
Source: FDA FAERS·Updated ·n=884,596+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flagReports% of total
Serious reports (any flag)——
Hospitalization——
Death reported as outcome
FAERS outcome flag, not a reaction term. The patient was on the drug when the report was filed; causation is not established.
38,8134.4%

Acetaminophen Recalls

FDA enforcement actions matched to acetaminophen via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →).

No recalls are on record for this drug in the FDA enforcement database.

Source: FDA Drug Enforcement Reports·Updated ·Refreshes every 6 hours·verify on FDA →

Acetaminophen Shortages

FDA-listed shortages of acetaminophen products. Strength and dosage-form level detail.

No active or recent shortages of acetaminophen are listed. We refresh this view daily.
Source: FDA Drug Shortages·Updated

Is Acetaminophen Safe?

Acetaminophen is FDA-approved and the label does not carry a boxed warning.

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (acetaminophen label)·Updated

FDA-Approved Indications

Acetaminophen is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

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
Source: DailyMed (acetaminophen label)·Updated ·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of acetaminophen?
Pain, fatigue, and nausea are among the most-reported reactions in FDA FAERS data for acetaminophen. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.
Is acetaminophen the same as Pain Relief?
Acetaminophen is the generic name; Pain Relief is a brand name for the same active ingredient. Other brand names include Heb, Arthritis Pain Relief, Eight Hour Pain Relief, Acetaminophen Extended-Release, Arthritis Pain, Medline, Arthritis Pain Reliever, Muscle Aches And Pains Acetaminophen Extended Release, Arthritis Pain Acetaminophen, Acetaminophen For Children, Fever Reducing Childrens, Pain Reliever Fever Reducer Childrens, Foster And Thrive Pain Reliever, Amazon Basic Care Acetaminophen, Acetaminophen Pain Reliever Fever Reducer, Feverall Childrens, Feverall Jr. Strength, Feverall Infants, Infants' Feverall, Members Mark Arthritis Pain, Basic Care Acetaminophen, Midol Long Lasting Relief, Good Sense Pain Relief Arthritis Pain, Major Acetaminophen, Equate Menstrual Pain Relief, Care One Arthritis Pain Relief, Period Pills By Biikay, Acetaminophen And Ibuprofen, Acetaminophen And Ibuprofen (Nsaid), Acetaminophen And Ibuprofen Back Pain, Dual Action Pain Relief, Aacetaminophen And Ibuprofen, and Tylenol. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.
Has acetaminophen been recalled?
No recalls of acetaminophen are on record in the FDA enforcement database in the period we index. This view refreshes from the FDA enforcement record every six hours.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

SourceEndpointRefresh
FAERS reactionsopenFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports.Daily
RecallsopenFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.6 hours
ShortagesFDA Drug Shortages list.Daily
Boxed warnings & label sectionsopenFDA /drug/label.json. Labels are stable; monthly cadence is sufficient.Monthly
Condition categoriesSynonym-mapped from drug_labels.indications. Methodology at /methodology/.Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.