Acetaminophen Safety: FAQ

Questions and Answers About Acetaminophen, Liver Damage Risk, and the FDA

Medically Reviewed by Louise Chang, MD on July 02, 2009
Written by Miranda Hitti
6 min read

An FDA advisory committee recently recommended that the FDA set certain limits on acetaminophen, a drug that is used in many prescription and nonprescription medicines to relieve pain and reduce fever.

Those limits could include taking off the market some prescription drugs, such as the painkillers Percocet and Vicodin, which combine acetaminophen with other active ingredients.

The reason for the proposed limits is the risk of liver damage from taking too much acetaminophen.

That risk isn't new, and the FDA advisory committees don't set policy -- that's the FDA's job, and the FDA hasn't decided what to do about acetaminophen yet.

But the FDA advisory committee meeting is drawing attention to acetaminophen. Here are questions and answers about the drug, its risks, its safe use, and how the FDA is handling it.

Acetaminophen is a drug found in many over-the-counter products (which are sold without a prescription) including Tylenol, aspirin-free Anacin, Excedrin, and numerous cold medicines. It's also found in many prescription medicines.

Acetaminophen is used as a pain reliever and fever reducer. It's the only active ingredient in some medicines; other medications combine acetaminophen with other active ingredients.

The FDA's web site notes that medicines containing acetaminophen come in many forms, including drops, syrups, capsules, and pills.

On its web site, the FDA states that "acetaminophen is an important drug, and its effectiveness in relieving pain and fever is widely known. This drug is generally considered safe when used according to the directions on its labeling. But taking more than the recommended amount can cause liver damage, ranging from abnormalities in liver function blood tests, to acute liver, failure, and even death."

No. It's a known risk that's already noted on drug labels.

The FDA has been concerned that despite efforts taken by the FDA and the drug industry over the years, some people still take too much acetaminophen and wind up with liver damage.

On June 29 and 30, three FDA advisory committees held a joint meeting to consider various options to try to reduce liver damage from acetaminophen use in over-the-counter and prescription drugs, including the painkillers Vicodin and Percocet.

Those options that the committees considered are as follows:

  • Lower the maximum total daily dose in over-the-counter products.
  • Limit the maximum single dose for adults taking over-the-counter products.
  • Switch the current maximum dose of acetaminophen to prescription status.
  • Limit pack sizes for over-the-counter acetaminophen products.
  • Eliminate over-the-counter products that combine acetaminophen with other drugs.
  • Make only one concentration of nonprescription liquid acetaminophen available.
  • Eliminate prescription drugs that combine acetaminophen with other drugs.
  • Require certain packaging changes for prescription drugs that combine acetaminophen with other drugs.
  • Require a "black box" warning (the FDA's sternest warning) for prescription medicines that combine acetaminophen with other drugs.

Here are the measures that advisory committees voted to recommend to the FDA:

  • Lower the maximum total daily dose in over-the-counter products: 21 yes votes, 16 no votes. The yes votes include 11 committee members who said this should be a high priority.
  • Limit the maximum single dose for adults taking over-the-counter products: 24 yes votes, 13 no votes. The yes votes include 12 committee members who said this should be a high priority.
  • Switch the current maximum dose of acetaminophen to prescription status: 26 yes votes, 11 no votes. The yes votes include eight committee members who said this should be a high priority.
  • Make only one concentration of nonprescription liquid acetaminophen available: 36 yes votes, 1 no vote. The yes votes include 19 committee members who said this should be a high priority.
  • Eliminate prescription drugs that combine acetaminophen with other drugs: 20 yes votes, 17 no votes. The yes votes include 10 committee members who said this should be a high priority.
  • Require certain packaging changes for prescription drugs that combine acetaminophen with other drugs: 27 yes votes, 10 no votes. The yes votes include five committee members who said this should be a high priority.
  • Require a "black box" warning (the FDA's sternest warning) for prescription medicines that combine acetaminophen with other drugs: 36 yes votes, 1 no vote. The yes votes include 25 committee members who said this should be a high priority.

Here are the measures that the FDA advisory committees did not recommend:

  • Limit pack sizes for over-the-counter acetaminophen products: 17 yes votes, 20 no votes. The yes votes include two committee members who said this should be a high priority.
  • Eliminate over-the-counter products that combine acetaminophen with other drugs: 13 yes votes, 24 no votes. The yes votes include two committee members who said this should be a high priority.

For more on the FDA advisory committee vote, and reactions from the drug industry, read WebMD's news story, filed on the day of the committee vote.

No. FDA advisory committees make recommendations, but they don't set policy. That's the FDA's job.

The FDA has the final word on how to handle acetaminophen. The FDA often follows the advice of its advisory committees, but it's not required to do so. It could accept some, all, or none of the recommendations.

There is no set deadline for the FDA to do that. It could take months. When the FDA acts on acetaminophen, WebMD will cover that news.

The key with acetaminophen -- or any other drug -- is to take it exactly as instructed by your doctor or the drug label. Taking too much, even a little too much, is risky, even if you didn't need a prescription to get it.

Here are some specific tips from the FDA's web site:

  • Read all the information given to you by your doctor and follow directions.
  • Follow directions on the "Drug Facts" label of over-the-counter products.
  • Be sure you understand the dose (how much acetaminophen you can take at one time), how many hours you must wait before taking another dose of acetaminophen, how many doses of acetaminophen you can take safely each day, and when to stop taking acetaminophen and ask a doctor for help.
  • Never take more than directed, even if your pain or fever isn't any better.
  • Never take more than one medicine that contains acetaminophen.
  • Check the active ingredients of all your medicines to make sure you're taking no more than one medicine containing acetaminophen at a time.
  • Know that some prescription drug labels may abbreviate acetaminophen as "APAP." The same precautions still apply.
  • Talk to your doctor before taking acetaminophen if you drink alcohol, have liver disease, or take the blood thinner warfarin.

Yes. The same principles that apply for adults also apply to children, and teens:

  • Don't take more than the recommended amount.
  • Don't take more than one medicine containing acetaminophen. That includes prescription and nonprescription (over-the-counter) products.
  • Follow directions strictly.

The FDA recommends also taking these steps when giving acetaminophen to children:

  • Choose the right medicine based on the child's weight and age. Check the "Directions" section of the "Drug Facts" label on over-the-counter products to see if the medicine is right for your child, how much medicine to give, how many hours to wait before giving another dose, and when to stop giving acetaminophen and ask a doctor for help.
  • Use measuring tools that come with the medicine. Don't use a spoon that's meant to be used for cooking or eating. If you don't have the measuring tool that came with the medicine, ask your pharmacist for one.
  • Keep a record of what doses you gave the child and when.
  • Keep all medicines where they can't be seen or reached by children -- a locked box, cabinet, or closet is best.

Call 911 or Poison Control (800-222-1222) immediately to find out what to do, even if you aren't sick. The FDA notes that the signs and symptoms of liver damage may not be noticeable for hours or even days after taking acetaminophen, and by the time you notice changes, you may already have severe liver damage that could lead to death.

It's up to the FDA to decide that. That decision hasn't been made yet. When it is, WebMD will bring you that news.