Over-the-counter medication · Analgesic / Antipyretic
acetaminophen
Also sold as Tylenol. This medicine temporarily relieves minor aches and pains.
- 417,458
- FDA reportsHeavily reported
- 23
- InteractionsSeveral interactions
- 8
- Recall records
What the data shows
acetaminophen (Tylenol) is an over-the-counter Analgesic / Antipyretic, one of the most-reported medications in the FDA FAERS database (417,458 FDA reports), with 23 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
acetaminophen (Tylenol) is an over-the-counter Analgesic / Antipyretic. This medicine temporarily relieves minor aches and pains.
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever. It is available over-the-counter.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.29/unit
Generic Available
Yes (35 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine temporarily relieves minor aches and pains.
Common side effects
Headache, Nausea
Key warnings
Taking more acetaminophen than directed can cause liver damage.
The sections below are summarized in plain English from acetaminophen's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Acetaminophen's exact mechanism is not fully understood. It is believed to work in the brain to reduce pain signals. It also helps to lower body temperature when you have a fever.
How to Take It
Adults and children 12 years and over can take 2 gelcaps every 6 hours as needed. Do not take more than 6 gelcaps in 24 hours, unless your doctor tells you to. Do not take this medicine for more than 10 days unless your doctor tells you to. Children under 12 years old should ask a doctor.
This is a plain-language summary of acetaminophen's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
If you are pregnant or breastfeeding, talk to your doctor before using this medicine. They can help you weigh the risks and benefits.
This is a plain-language summary of acetaminophen's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. Do not take more than the recommended dose at one time.
This is a plain-language summary of acetaminophen's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature (77°F), and avoid high humidity.
Side Effects (from patient reports)
Based on 417,458 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for acetaminophen, by number of reports
- Tiredness
Tiredness
34,486 reports
- Feeling sick to your stomach
Feeling sick to your stomach
29,571 reports
- Head pain
Head pain
28,378 reports
- Aches
Aches
28,322 reports
- Loose stool
Loose stool
23,628 reports
- Difficulty breathing
Difficulty breathing
22,691 reports
- Joint pain
Joint pain
22,204 reports
- Throwing up
Throwing up
20,752 reports
- Fever
Fever
19,561 reports
- Skin irritation
Skin irritation
17,645 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for acetaminophen each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where acetaminophen sits
acetaminophen has more FDA adverse-event reports than 99% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is acetaminophen; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 417,458 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1998–2025.
Total Reports
417,458
Reports Mentioning Death
58,910
14.1% of reports — not proof of cause
Hospitalization Reports
150,224
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 34,487 |
| 4 | NAUSEA | 29,567 |
| 5 | HEADACHE | 28,380 |
| 6 | PAIN | 28,314 |
| 7 | DIARRHOEA | 23,626 |
| 8 | DYSPNOEA | 22,688 |
| 9 | ARTHRALGIA | 22,202 |
| 10 | VOMITING | 20,745 |
| 11 | PYREXIA | 19,557 |
| 12 | RASH | 17,645 |
| 13 | DIZZINESS | 16,828 |
| 14 | ASTHENIA | 15,832 |
| 15 | PNEUMONIA | 15,767 |
| 16 | MALAISE | 15,530 |
| 17 | TOXICITY TO VARIOUS AGENTS | 15,385 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Taking more acetaminophen than directed can cause liver damage. Follow the dosage instructions carefully.
Known Drug Interactions
7.4 Concomitant Use with Drugs that Induce Methemoglobinemia Concomitant use of ACZONE Gel, 7.5% with drugs that induce methemoglobinemia such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para‐aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine may increase the risk for developing methemoglobinemia [see Warnings and Precautions ( 5.1 )] .
Mechanism: Both drugs can cause a rare blood condition where red blood cells cannot carry oxygen properly. Taking them together increases the risk of this problem occurring.
What to do: Use these medications together with caution and watch for signs of low oxygen, such as blue-tinted skin or shortness of breath.
Drugs That May Cause Methemoglobinemia When Used with LIDODERM Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia : Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea,...
Mechanism: Both of these drugs can change how your red blood cells carry oxygen, which might lead to a rare but serious blood condition.
What to do: Your doctor should monitor you closely for signs of low oxygen if you use these medications at the same time.
Alcohol, ethyl Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen. Oral Contraceptives Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen. Charcoal (activated) Reduces acetaminophen absorption when administered as soon as possible after overdose.
Mechanism: Taking both of these medicines at the same time means you are getting the same active ingredient from two different sources, which can lead to a dangerous buildup in your liver.
What to do: Avoid taking any other products that contain acetaminophen while using this medicine. Check the labels of all over-the-counter drugs to ensure you do not exceed the safe daily limit.
In addition, carbamazepine causes, or would be expected to cause, decreased levels of the following drugs, for which monitoring of concentrations or dosage adjustment may be necessary: acetaminophen, albendazole, alprazolam, aprepitant, buprenorphone, bupropion, citalopram, clonazepam, clozapine, corticosteroids (e.g., prednisolone, dexamethasone), cyclosporine, dicumarol, dihydropyridine calcium channel blockers (e.g., felodipine), doxycycline, ethosuximide, everolimus, haloperidol, imatinib, itraconazole, lamotrigine, levothyroxine, methadone, methsuximide, mianserin, midazolam,...
Mechanism: Carbamazepine causes your body to process acetaminophen more quickly, which may prevent it from working well for pain.
What to do: Your doctor may need to adjust your dose or suggest a different medicine for pain relief.
Drug Interactions Probenecid Probenecid is known to interact with the metabolism or renal tubular excretion of many drugs (e.g., acetaminophen, acyclovir, angiotensin-converting enzyme inhibitors, aminosalicylic acid, barbiturates, benzodiazepines, bumetanide, clofibrate, methotrexate, famotidine, furosemide, nonsteroidal anti-inflammatory agents, theophylline, and zidovudine).
Mechanism: Probenecid is taken alongside cidofovir and can interfere with how your body processes and removes acetaminophen. This could result in higher levels of acetaminophen in your system.
What to do: Check with your doctor before using acetaminophen while receiving cidofovir. They may recommend a lower dose to ensure your safety.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What is acetaminophen used for?
How often can I take acetaminophen?
Can I take acetaminophen if I am pregnant?
Can children take acetaminophen?
What should I do if I miss a dose?
How many gelcaps can I take in a day?
Can I take acetaminophen for a long time?
What happens if I take too much acetaminophen?
How should I store acetaminophen?
Does acetaminophen cure my cold?
What are the common side effects of acetaminophen?
Does acetaminophen interact with other medications?
What drug class is acetaminophen?
Is acetaminophen safe during pregnancy?
Has acetaminophen been recalled?
Active Recalls
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx, LLC
Defective Container
Kenvue Brands LLC
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc.
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Global Corporation
Microbial Contamination of Non-Sterile Products
Haleon US Holdings LLC
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
What the FDA Data Shows for acetaminophen
The FDA label for acetaminophen (sold under brand names such as Tylenol) classifies it as an over-the-counter product in the Analgesic / Antipyretic class. This medicine temporarily relieves minor aches and pains. Official labeling lists 2 commonly reported side effects, including Headache, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 417,458 voluntary reports. The database also lists 23 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.29.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 8 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 14, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages