What You Need to Know About Acetaminophen (Tylenol)
Acetaminophen, also called Paracetamol, is used to relieve pain and reduce fever in the United States and other countries. Acetaminophen is sold over the counter and is also combined with other drugs, usually opioids such as codeine, to make stronger painkillers.
It’s one of the most commonly used drugs in the country but it was called the number one cause of liver failure in the United States in 2007. 1
What is Acetaminophen?
Acetaminophen (Paracetamol) was developed from coal tar in the late 1800s by the Bayer company in Germany, originally to reduce fever. 2
It can be bought over the counter as a fever reducer or painkiller, like Tylenol or many store brands, and is used in many prescription products in combination with other drugs, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). 3
Does Acetaminophen work?
Acetaminophen does reduce fever. Combinations of acetaminophen with other drugs can be effective in reducing pain and have been found to be more effective than acetaminophen alone. Acetaminophen is used in hundreds of over-the-counter and prescription medication combinations.4 The list of drugs made using combinations of acetaminophen and opiates or analgesics is very long. 5
What should I ask my doctor about before I decide to take Acetaminophen?
Too much acetaminophen can damage or destroy the liver. In 2002, FDA officials presented evidence to a panel that 100 people a year died of acetaminophen toxicity and more than 2000 people were hospitalized.6
In 2009, an FDA panel considered a ban on acetaminophen but then voted narrowly to ban only two drug combinations: Percocet and Vicodin. These two drugs are a combination of acetaminophen and a narcotic. Patients may be taking them for some time to deal with pain and the panel noted that over time, patients often needed to increase their dosage of these drugs to continue to achieve the same effects and that this could result in acetaminophen overdose. 7
The panel recommended that the FDA reduce the amount of acetaminophen in combination medications similar to Vicodin and Percocet. 8
The FDA issued a warning on drugs containing combinations of acetaminophen and opioids and asked drug makers to lower the amount of acetaminophen in their drugs to no more than 325mg per dosage by 2014. The FDA also instituted a requirement for drugs containing a combination of acetaminophen to carry a black box warning on the danger of liver toxicity. 9
Some combinations of paracetamol (acetaminophen) have been banned in the United Kingdom and studies have shown that this ban has reduced the number of suicide deaths in the UK. 10
Exceeding the maximum recommended daily dose, 4 grams in a 24-hour period by an adult and lower dosages for children by weight, can result in injury to the liver, up to and including liver failure and death. Many case of acetaminophen overdose are accidental, as people don’t realize they’ve taken too much. 11
Small amounts of the acetaminophen we take are converted in the body into a toxin, which binds with proteins in the liver and causes injury to liver cells. If there’s too much of the toxin and the liver can’t remove it before it binds to those proteins, there will be damage to the liver and the liver can fail completely. 12
Acetaminophen overdose is still a common, if not the most common, cause of liver injury and liver failure in the US. 13
Acetaminophen is in many products and someone may be taking multiple products containing it and not notice. For example, someone might take a tablet for headache or to lower temperature, then a bit later cough syrup, then a liquid cold remedy, all of which could contain the recommended maximum dosage. Acetaminophen may be listed on the ingredients under other names, such as APAP, and not be immediately recognizable. 14
Some people may be more susceptible to acetaminophen overdose than others and a very small amount over the recommended maximum dosage may be enough to start the process of liver damage. Symptoms of liver injury can look like the flu and a person who’s suffering from it may not have any idea that there’s anything wrong with their liver until it’s too late. 15
Parents accidentally give babies and children an acetaminophen overdose many different ways. They may combine medications and not be aware that they’re giving their baby or child an overdose, they may give a baby or toddler a medication meant for an older child and accidentally give an overdose. 16
What can I do if I am worried about Acetaminophen?
There are many alternatives to acetaminophen, both other prescription and over-the-counter medications and non-drug methods to reduce fever or relieve pain. The danger of taking acetaminophen is too great for casual or unnecessary use. If you are really in need of prescription medication, talk to your doctor about using acetaminophen safely and alternatives to it.
Learn everything that you can about Acetaminophen before you start taking it.
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1 Proc Natl Acad Sci USA, Bushel P.R. et al., “Blood gene expression signatures predict exposure levels” (13 November 200&), http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2084322/?tool=pmcentrez
2 Royal Society of Chemistry, “Pain relief: from coal tar to paracetamol” (July, 2005, http://www.rsc.org/education/eic/issues/2005july/painrelief.asp
3 Food and Drug Administration, “New Steps Aimed at Cutting Risks from Acetaminophen” (last updated 8 December 2011, retrieved 15 August 2012), http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm239747.htm
4 Food and Drug Administration, “Acetaminophen information,” http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm; Journal Watch Emergency Medicine, Brown, Emily and Walls, Ron, “Analgesia: Are Acetaminophen/NSAID Combinations More Effective Than One Drug Alone? ” (9 April 2010), http://emergency-medicine.jwatch.org/cgi/content/full/2010/409/1
5 Food and Drug Administration, “List of Marketed Acetaminophen-Containing Prescription Products” (last updated 21 January 2011, retrieved 15 August 2012), http://www.rsc.org/education/eic/issues/2005july/painrelief.asp
6 New York Times, Stoleberg Sheryl, “Warnings Sought for Popular Painkiller,” (20 September 2002), http://www.nytimes.com/2002/09/20/us/warnings-sought-for-popular-painkiller.html
7 New York times, Harris, Gardiner, “Ban Is Advised on 2 Top Pills for Pain Relief” (30 June 2009), http://www.nytimes.com/2009/07/01/health/01fda.html
8 Ibid.
9 FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure
http://www.fda.gov/Drugs/DrugSafety/ucm239821.htm
10 BBC News, “Painkiller ban has ‘cut suicides’,” (18 June 2009) http://news.bbc.co.uk/2/hi/health/8107546.htm
11 Food and Drug Administration, Advisory Committee Meeting Materials, “Acetaminophen Overdose and Liver Injury – Background and Options for Reducing Injury,” (2009) http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf
12 Ibid.
13 Ibid.
14 Ibid.
15 Ibid.
16 MayoClinic.com, Mayo clinic staff, “Acetaminophen and children: Why dose matters,” http://www.mayoclinic.com/health/acetaminophen/HO00002