Attachment D1 -- Post Participation Education

Consumer Health Information
www.fda.gov/consumer

Acetaminophen
and Liver Injury:
Q & A for Consumers

O

n June 29 and 30, 2009,
FDA held an advisory
committee meeting in
Adelphi, Md., about how to
address the problem of liver
injury related to the use
of acetaminophen in both
over-the-counter (OTC) and
prescription products. For
more information about the
meeting, visit www.fda.gov/
AdvisoryCommittees/Calendar/
ucm143083.htm
Acetaminophen is the generic name
of a drug found in many common
brand name OTC products such as
Tylenol, as well as prescription products such as Vicodin and Percocet.
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.

The liver has an important role in removing drugs from
the blood and eliminating them from the body, but it is
also susceptible to damage from drugs.

1 / FDA Consumer Health Infor mat ion / U. S. Food and Drug Administrat ion

Artville

JUNE 2009

Consumer Health Information
www.fda.gov/consumer

Don’t take more than one medicine that
contains acetaminophen at a time.
Q: What is acetaminophen?
A: Acetaminophen (pronounced:
a∙seet·a·min·o·fen), is an active
ingredient found in many OTC and
prescription medicines to help relieve
pain and reduce fever.
It is also found in combination
with other active ingredients, called
combination medicines, which treat
conditions such as:
• symptoms of colds and flu
• allergy
• sleeplessness
Medicines containing acetaminophen are available in many forms,
including drops, syrups, capsules,
and pills.
Many people call OTC acetaminophen by a brand name, Tylenol.
Others may know Percocet or Vicodin, which are prescription brand
names that contain acetaminophen
and other active ingredients to help
relieve pain.
You might see acetaminophen
abbreviated as “APAP” on prescription medicines.
In other countries, acetaminophen
may have a different name. For example, acetaminophen is known as paracetamol in the United Kingdom.
Q. Are there risks from taking too much
acetaminophen?
A: Yes, acetaminophen can cause
serious liver damage if you take too
much. It is very important to follow
your doctor’s directions and the directions on the medicine label.
You may not notice the signs and
symptoms of liver damage right away
because they take time to appear. Or,
you may mistake early symptoms of

liver damage (for example, loss of
appetite, nausea, and vomiting) for
something else, like the flu. Liver
damage can develop into liver failure
or death over several days.
Acetaminophen is generally safe
when taken as directed. To lower your
risk of liver damage make sure you do
the following:
• Follow dosing directions and never
take more than directed; even a
small amount more than directed
can cause liver damage.
• Don’t take acetaminophen for more
days than directed.
• Don’t take more than one medicine
that contains acetaminophen at a
time. For example, your risk of liver
damage goes up if you take a medicine that contains acetaminophen to
treat a headache, and while that medicine is still working in your body, you
take another medicine that contains
acetaminophen to treat a cold.
Q: How can I tell which medicines contain acetaminophen?
A: Medicines have ingredients listed
on their labels. On OTC medicines,
check the “Drug Facts” label under
the section called Active Ingredients.
If your medicine contains acetaminophen, it will be listed in this section.
On prescription medicine containers,
the label will say “acetaminophen”
or “APAP.”
Q: When should I talk to a doctor
before taking acetaminophen?
A: Talk to your doctor before taking
acetaminophen if you
• drink alcohol (three or more drinks
every day)
• have liver disease

2 / FDA Consumer Health Infor mat ion / U. S. Food and Drug Administrat ion

Under these conditions, taking
acetaminophen puts you at greater
risk of getting liver damage, even
when taking acetaminophen at the
recommended dose.
If you take the blood thinner warfarin, you should also talk to your
doctor before taking acetaminophen
because taking warfarin and acetaminophen together may raise your
risk of bleeding.
Q: How can I safely take acetaminophen?
A: Follow this advice to take acetaminophen safely:
• R ead all the information given
to you by your doctor and follow
directions.
• Read the information on the OTC
“Drug Facts” label or on the prescription label and follow directions.
• B e sure you understand the following:
- the dose, which is 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
- 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.
Taking more acetaminophen than
directed can put you at risk for liver
damage.
• Never take more than one medicine that contains acetaminophen.
Check the active ingredients of all
your medicines to make sure you
are taking no more than one mediJUNE 2009

Consumer Health Information
www.fda.gov/consumer

Keep medicine where it can’t be seen or
reached by children and pets.
cine containing acetaminophen at
a time.
Q: How can I safely give acetaminophen to my child?
A: You can safely give acetaminophen
to infants, children, and teenagers
if you
• Check the active ingredients in the
other medicines that your child is
taking (or that your child may take)
to make sure they don’t contain the
active ingredient acetaminophen.
Your child should never be taking
more than one medicine containing
acetaminophen at a time.
• R ead all the information given
by your child’s doctor and follow
directions.
• Read the information on the OTC
“Drug Facts” label or on the prescription label and follow directions.
• Choose the right medicine based
on your child’s weight and age. On
OTC medicines, the Directions section of the “Drug Facts” label tells
you:
- if the medicine is right for your
child
- how much medicine to give
- how many hours you must wait
before giving another dose
- when to stop giving acetaminophen and ask a doctor for help
If a dose for your child’s weight
or age is not listed on the label, or
you can’t tell how much to give,
ask your pharmacist or doctor what
to do.
• Use the measuring tool that comes
with the medicine. It will give the
exact dose. If you don’t have the
right measuring tool, ask a pharmacist. Don’t use a spoon that’s meant

to be used for cooking or eating. A
spoon should not be used to measure medicine because it may give
the wrong amount.
• Never give more than one medicine
that contains acetaminophen. If
you give more, it could harm your
child.

Prevent medicine accidents:
• Keep a record of the medicines you
give your child. Write down the
dose and time when you give the
medicine. This will help everyone
who cares for your child know how
much medicine your child has had.
This will help everyone avoid giving
an extra dose by mistake.
• K eep medicine where it can’t be
seen or reached by children and
pets; a locked box, cabinet, or closet
is best.
Q: What should I do if the pain or
fever doesn’t get better after taking
acetaminophen as directed?
A: Take the medicine only as directed.
Don’t take more. If the medicine
doesn’t help you feel better, talk to
your doctor, nurse, or pharmacist.
Q: What should I do if I took too much
acetaminophen? What should I do if
I gave too much acetaminophen to my
child?

Q: Where can I get more information
on acetaminophen?
A:
• Talk to a doctor, nurse, or
pharmacist.
• Visit FDA’s consumer Web pages at:
www.fda.gov/Drugs/
ResourcesForYou/Consumers/
BuyingUsingMedicineSafely/
UnderstandingOver-theCounterMedicines/SafeUseofOver-theCounterPainRelieversandFeverReducer
s/default.htm
A Guide to Safe Use of Pain
Medicine
www.fda.gov/ForConsumers/
ConsumerUpdates/ucm095673.htm
• Contact the FDA at 1-888-INFOFDA.
• Or, email questions to FDA at
[email protected]
This article appears on FDA’s
Consumer Updates page (www.fda.
gov/ForConsumers/ConsumerUpdates/
default.htm), which features
the latest on all FDA-regulated
products.

A: Don’t wait! Call 9-1-1 or Poison
Control at 1-800-222-1222 right away
to find out what to do. The signs or
symptoms of liver damage may not
be noticeable for hours or even days
after taking acetaminophen. By the
time you notice changes, the liver
damage may be severe and could lead
to death.

3 / FDA Consumer Health Infor mat ion / U. S. Food and Drug Administrat ion

JUNE 2009