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. FDA reports 12 active Class II recalls of acetaminophen, primarily for failed dissolution specifications. 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.
| Reaction | Reports | % of total |
|---|---|---|
| Pain | 60,357 | 6.8% |
| Fatigue | 56,016 | 6.3% |
| Nausea | 53,390 | 6.0% |
| Headache | 48,566 | 5.5% |
| Overdose | 44,032 | 5.0% |
| Diarrhoea | 39,488 | 4.5% |
| Dyspnoea | 38,072 | 4.3% |
| Vomiting | 35,978 | 4.1% |
| Arthralgia | 34,890 | 3.9% |
| Dizziness | 31,905 | 3.6% |
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 flag | Reports |
|---|---|
| Serious reports (any flag) | 609,135 |
| Hospitalization | 259,046 |
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 →); closed recalls are grouped in the disclosure that follows.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2026-03-25 | Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. STRIDES PHARMA INC | Class II | 89592 bottles | Ongoing |
| 2025-11-05 | Defective Container Kenvue Brands LLC | Class II | 3,816 bottles | Ongoing |
| 2025-09-03 | Discoloration Baxter Healthcare Corporation | Class II | 13,000 containers | Ongoing |
| 2025-06-25 | cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). Aurobindo Pharma USA Inc | Class II | 4,608 bottles | Ongoing |
| 2024-11-27 | Failed Tablet/Capsule Specifications Dr. Reddy's Laboratories, Inc. | Class III | 3416 botttles | Ongoing |
| 2024-09-04 | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. Dr. Reddy's Laboratories, Inc. | Class II | 14940 bottles | Ongoing |
| 2024-09-04 | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. Dr. Reddy's Laboratories, Inc. | Class II | 103,298 bottles | Ongoing |
| 2024-09-04 | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. Dr. Reddy's Laboratories, Inc. | Class II | 31,802 bottles | Ongoing |
| 2024-08-28 | Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) Hikma Pharmaceuticals USA Inc. | Class I | 31,400 bags | Ongoing |
| 2024-07-03 | Discoloration: Brownish tablets Contract Pharmacal Corporation | Class II | 14,616 bottles | Ongoing |
| 2023-12-13 | Failed Impurities/Degradation Specifications KINDER FARMS LLC | Class II | 376,370 bottles | Ongoing |
| 2023-12-13 | Failed Impurities/Degradation Specifications KINDER FARMS LLC | Class II | 591,684 bottles | Ongoing |
Show 8 closed recalls (2022 to 2024)
Includes resolved and terminated recalls matched to acetaminophen. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2024-08-14 | Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets. A-S Medication Solutions LLC | Class I | 429 bottles | Terminated |
| 2023-05-31 | Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity. Aurobindo Pharma USA Inc. | Class II | 87,360 bottles | Completed |
| 2022-08-24 | Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment. Baxter Healthcare Corporation | Class II | 85,680 bags | Terminated |
| 2022-06-15 | cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office | Class II | 1 carton/100 blisters per carton | Terminated |
| 2022-03-02 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC | Class II | 117552 bottles | Terminated |
| 2022-03-02 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC | Class II | 83760 packs | Terminated |
| 2022-03-02 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC | Class II | 111,888 bottles | Terminated |
| 2022-03-02 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC | Class II | 4,992 bottles | Terminated |
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.
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.
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
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?
Yes. Acetaminophen has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by contamination or foreign material, CGMP deviations, and mislabeling. See the recalls table on this page for current counts, firm names, dates, and lot quantities.
What are acetaminophen's current ongoing recalls about?
Active acetaminophen recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reasons across these recalls are contamination or foreign material, CGMP deviations, and mislabeling. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.
What do FDA recall classes mean?
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /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 |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-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.