FDA Consumer magazine
Acetaminophen is a safe and effective pain reliever that benefits millions
of consumers. However, taking too much could lead to serious liver damage. The
drug is sold under brand names such as Tylenol and Datril, but it is also available
in many cough and cold products and sleep aids, and is an ingredient in many
prescription pain relievers.
In September 2002, the FDA Non-Prescription Drugs Advisory Committee discussed
safety issues related to the use of pain relievers sold over-the-counter (OTC),
including acetaminophen, aspirin, ibuprofen and naproxen.
Acetaminophen can cause liver injury through the production of a toxic metabolite.
The body eliminates acetaminophen by changing it into substances (metabolites)
that the body can easily eliminate in the stool or urine. Under certain circumstances,
particularly when more acetaminophen is ingested than is recommended on the
label, more of the harmful metabolite is produced than the body can easily eliminate.
This harmful metabolite can seriously damage the liver.
The signs of liver disease include abnormally yellow skin and eyes (jaundice),
dark urine, light-colored stools, nausea, vomiting, and loss of appetite. The
signs can be similar to flu symptoms and may go unnoticed for several days if
consumers believe their symptoms are related to their initial illness. Serious
cases of liver disease may lead to mental confusion, coma, and death.
To avoid accidental overdosing, it's very important not to take more than the
recommended dose on the label. Also, you should not take acetaminophen for more
days than recommended, or take more than one drug product that contains acetaminophen
at the same time. Consumers should be aware that taking more than the recommended
dose will not provide more relief.
If you're taking a prescription pain medicine, check with your doctor first
before taking OTC acetaminophen. The prescription pain medicine may also contain
acetaminophen. Acetaminophen is also available in combination with other OTC
drug ingredients. So, you need to check the labels of other OTC drug products
for the ingredient. In some cases of accidental acetaminophen overdose, it appears
that consumers used two or more acetaminophen-containing products at the same
Some individuals appear to be more susceptible to acetaminophen-induced liver
toxicity than others. People who use alcohol regularly may be at increased risk
for toxicity, particularly if they use more than the recommended dose. Further
research needs to be conducted in alcohol users to determine what factors make
some alcohol users more susceptible to liver injury than others.
Parents should be cautious when giving acetaminophen to children. For example,
the infant drop formula is three times more concentrated than the children's
suspension. It's important to read drug labels every time you use a drug and
to know what dosage strength you are using.
Improvements to labeling and consumer information for acetaminophen are among
the recommendations made by the FDA's Nonprescription Drugs Advisory Committee.
The committee recommended including the word "acetaminophen" in bold
type on the labels for all drug products containing the ingredient and a warning
about acetaminophen's potential to cause liver damage.
The committee also recommended that labeling for aspirin and other non-steroidal
anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen include warnings
about the potential for gastrointestinal bleeding that may be associated with
use of these products. Aspirin is sold under brand names such as Bayer and St.
Joseph's. Ibuprofen is sold under names such as Advil and Motrin. Naproxen is
sold under the name Aleve. There are generic versions available for all of these
products, as well.
The risk for bleeding is low for those who take these products intermittently.
For those who take the products on a daily or regular basis, the risk is increased,
particularly for those over 65 years of age or those who take corticosteriods
(such as prednisone). Those who use hormone therapy (estrogens and progestins)
for post-menopausal symptoms or birth control do not have an increased risk
In addition, the committee recommended adding labeling language that urges
consumers to ask health care providers about NSAID use if they have kidney disease
or are taking diuretics (fluid pills).
The FDA is evaluating the committee's advice and working to complete rulemaking
for these OTC pain relievers/fever reducers.