Acetaminophen
What you should know about using acetaminophen safely
What is Acetaminophen?
Acetaminophen is a drug that is used to:
- Temporarily relieve pain
- Temporarily reduce fever
Acetaminophen is found in hundreds of over-the-counter and prescription drugs. It may be the only active ingredient, or it may be combined with other active ingredients.
Acetaminophen is sold under many different brand names. In addition, abbreviations for acetaminophen – such as APAP, Acetaminoph, Acetaminop, Acetamin and Acetam – may be used on prescription labels. Outside of the United States, acetaminophen is commonly known as paracetamol.
Acetaminophen is available in different forms:
- Tablets, including extended-release (long-acting) or chewable tablets
- Capsules
- Liquids
- Powders
- Suppositories (for rectal use)
Safe Use of Acetaminophen
Acetaminophen is safe and effective when used as directed.
To ensure safe use of acetaminophen:
- Always read the label of every over-the-counter and prescription drug before use.
- Know if you are taking drugs that contain acetaminophen. Both over-the-counter and prescription drugs may contain acetaminophen.
- Do not use more than one acetaminophen-containing product at a time. Acetaminophen is in many products. You could accidentally take too much if you use more than one product containing acetaminophen at a time.
- Follow dosing directions on the label. Make sure you understand:
- How much you can take at one time (dose)
- How many hours you must wait before taking another dose
- How many times you can take it each day
- When you should not take it and talk to your health care professional
- Never take more acetaminophen than what the label says, even if you still have fever or pain. Taking too much acetaminophen can cause liver failure and death.
- Ask your health care professional before use if you have liver disease.
- Be aware that severe liver damage may occur if you have three or more alcoholic drinks per day while using acetaminophen.
- Inform your health care professional of all drugs (prescription and over-the-counter), vitamins, and supplements you take. Ask your health care professional if any of your drugs contain acetaminophen, especially when receiving a new prescription.
The maximum total amount of acetaminophen taken in 24 hours should not be more than 4,000 mg for adults and children 12 years of age and older.
Ask your health care professional if you have questions about drugs that contain acetaminophen. If you think you have taken too much acetaminophen, get medical help or contact Poison Help at 1-800-222-1222 right away.
Specific Safety Topics
FDA continuously monitors and reviews scientific data on the safe use of acetaminophen. FDA regularly takes action to improve the safety of this drug. Report side effects from pain medicines to the FDA MedWatch program online or by calling 1-800-FDA-1088.
Taking too much acetaminophen, also known as an acetaminophen overdose, is unsafe and can lead to liver failure and death. FDA has previously communicated to the public about how too much acetaminophen can lead to severe liver damage. That is why the agency has taken steps to reduce the risk of overdose by limiting the amount of acetaminophen allowed in prescription drugs, requiring label changes for over-the-counter drugs containing acetaminophen, and requiring manufacturers to take certain actions for prescription drugs containing acetaminophen.
Click here for important information on the safe use of acetaminophen.
Acetaminophen may cause rare but serious skin reactions. In 2024, FDA proposed adding a warning to the label for over-the-counter acetaminophen-containing products about the risk of severe skin reactions. The agency previously communicated about this risk to the public.
Important information you should know when taking acetaminophen:
- Symptoms of severe skin reactions may include skin reddening, rash, blisters, and detachment of the upper surface of the skin.
- Serious skin reactions can occur even if you have taken acetaminophen in the past without any problems.
- If you develop any skin rash or reaction while using a medication containing acetaminophen, stop the medication and seek medical attention immediately. A health care professional should evaluate you to determine if you are experiencing a serious skin reaction.
- If you have had a serious skin reaction with acetaminophen, do not take any products containing acetaminophen again. Doing so could cause you to have another serious skin reaction.
- Other medicines used for the temporary relief of fever and pain (e.g., nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen and naproxen) also carry the risk of causing serious skin reactions. However, having experienced a serious skin reaction with acetaminophen does not necessarily mean that you will also experience the reaction with other medicines.
It is important that parents and caregivers give the correct dose of acetaminophen-containing products to their infants and children. FDA has communicated about potential confusion related to concentration differences among liquid acetaminophen products in the past. FDA has also answered some common questions and answers that parents and caregivers may have about these products. In addition, FDA has issued a guidance for industry on liquid drugs that contain acetaminophen.
When giving a product that contains acetaminophen to infants and children:
- Read the Drug Facts label before use.
- Identify the correct dose based on the dosing directions. Do not give more than the recommended dose based on the dosing directions.
- Do not give more than one product that contains acetaminophen at a time.
- Do not use a product intended for adults if the child is less than 12 years of age.
- If giving liquid acetaminophen, use the dosing device provided with the product. Do not use a kitchen spoon or a dosing device from a different product. Contact your child’s health care professional if you are unsure how to measure a dose.
The use of any medicine during pregnancy should be carefully considered. In 2015, FDA communicated safety findings to the public about the use of pain medicine during pregnancy. FDA continues to monitor and evaluate the use of pain medicine, including acetaminophen, during pregnancy. To date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes. However, FDA continues to recommend consultation with a health care professional before use of any medicine, including acetaminophen, during pregnancy.
If you are pregnant:
- Consult your health care professional about the use of all prescription and over-the-counter drugs, vitamins, and supplements.
- Do not stop taking any prescribed drugs without first talking to your health care professional.
- Talk to your health care professional if you have any questions or concerns about drugs you are taking.