Acetaminophen: What to Know Before You Take It
Also known as Tylenol
A patient-focused safety profile with information from public regulatory sources.
In plain language
What Acetaminophen is used for
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
Read before you decide
Risks and precautions
Risks and warnings
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. Do not use if you are allergic to acetaminophen or any of the inactive ingredients in this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Medication review
Acetaminophen drug interactions
FDA safety data
Most-reported side effects
Based on 668,254 FAERS reports. Reports do not prove the drug caused the effect.
Regulatory record
FDA recalls (20)
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Recalling firm: SpecGx, LLC
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Recalling firm: SpecGx, LLC
Defective Container
Recalling firm: Kenvue Brands LLC
Discoloration
Recalling firm: Baxter Healthcare Corporation
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Recalling firm: Aurobindo Pharma USA Inc
CGMP Deviations
Recalling firm: Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Released product should have been rejected.
Recalling firm: LNK International, Inc.
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Recalling firm: Denison Pharmaceuticals, LLC
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Recalling firm: Denison Pharmaceuticals, LLC
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Recalling firm: Aurobindo Pharma USA Inc
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)
Recalling firm: Hikma Pharmaceuticals USA Inc.
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.
Recalling firm: A-S Medication Solutions LLC
Everyday context
Food and drink interactions
Common questions
Patient questions
What is Acetaminophen prescribed for?
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
What are the key warnings and safety precautions for Acetaminophen?
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. Do not use if you are allergic to acetaminophen or any of the inactive ingredients in this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Does Acetaminophen interact with other medications or foods?
Acetaminophen has 6 documented drug interaction(s) and 1 food interaction(s) in clinical databases. Always provide your complete medication list to your clinician.
This information is educational — not medical advice.
This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.