The People's Perspective on Medicine

FDA Warning Highlights Tylenol Hazard

Tylenol (acetaminophen) side effects now include life-threatening skin reactions.

For decades acetaminophen (APAP, Tylenol, etc.) was considered the safest drug in the pharmacy. But over the last few years, accumulating evidence suggests that we may need to rethink our trust in Tylenol. A new FDA warning has refocused attention on this ubiquitous pain reliever.

Did you know that Tylenol was once available only by prescription? It was first introduced in 1955 as an elixir for alleviating pain and fever in children. The pills for adults became available without prescription in 1961.

The manufacturer, McNeil, presented Tylenol to the public and the medical profession as a safer alternative to aspirin. Acetaminophen is less likely than aspirin to cause intestinal irritation and bleeding, and the promotion naturally focused on that advantage. A mainstay of the advertising campaign was the slogan “Trust Tylenol…Tylenol is the pain reliever hospitals use most.”

Last week the FDA announced a new complication of acetaminophen, demonstrating that it can take more than 50 years to discover rare but serious side effects. Here is the official announcement:

“FDA notified healthcare professionals and patients that acetaminophen has been associated with a risk of rare but serious skin reactions. Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and over-the-counter (OTC) products.  These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken… Any patient who develops a skin rash or reaction while using acetaminophen or any other pain reliever/fever reducer should stop the drug and seek medical attention right away.” Aug 1, 2013

While rare, SJS, TEN and AGEP can be life threatening. The skin can literally separate from the body and slough off. These are all excruciating conditions.

Although the FDA will encourage manufacturers of acetaminophen products to warn consumers about these potential hazards, many people won’t bother to read the label. For one thing, they take Tylenol for granted. As an OTC drug that has been around for so long, acetaminophen is assumed to be super safe.

One survey showed that two thirds of those questioned did not know that Tylenol contains acetaminophen (American Journal of Preventive Medicine, May 3, 2011). Less than half bothered to read the label on OTC pain relievers. Most do not know if they are taking other drugs that contain acetaminophen. This might explain why there are too many unintentional overdoses that result in liver failure.

Other Acetaminophen Complications

Serious skin reactions are not the only worrisome side effects associated with acetaminophen. As just mentioned, liver failure is another potentially lethal adverse reaction (Pharmacotherapy, Sept. 2007). Long-term use of acetaminophen has also been linked with certain blood cancers. In one study of nearly 65,000 people, those who took acetaminophen-containing products at least four days a week for four years or more had nearly double the risk of being diagnosed with leukemia or lymphoma (Journal of Clinical Oncology, online May 9, 2011). 

Another potential complication associated with acetaminophen is asthma. Several studies have suggested that regular use might be linked to an increased risk of wheezing, asthma, allergies or eczema (Chest, Nov. 2009; American Journal of Respiratory and Critical Care Medicine, Jan. 15, 2011). Some experts believe that increased use of acetaminophen in kids might be contributing to the epidemic of childhood asthma (Pediatrics, Dec. 2011).

Hearing loss may not be life threatening, but it has a damaging impact on quality of life. Data from the Nurses’ Health Study II suggest that women may develop hearing loss if they take acetaminophen or ibuprofen on a regular basis. The investigators suggest that middle-aged women worried about hearing loss might not want to rely heavily on such medications for joint pain, menstrual cramps, backache or headache (American Journal of Epidemiology, Sept. 15, 2012). Men also appear susceptible to this adverse reaction (American Journal of Medicine, March, 2010).

There is also some concern that acetaminophen, like other non-aspirin pain relievers, may have negative cardiovascular effects such as increased blood pressure (Joint Bone Spine, July, 2013).

Acetaminophen Side Effects:



  • Liver damage/liver failure

  • Headache

  • Rash
 (any skin reaction must be reported to a doctor immediately as it could become life threatening)
  • Allergic reactions (anaphylaxis, which can be life threatening)

  • Kidney damage

  • Anemia

  • High blood pressure

  • Asthma, wheezing, atopic dermatitis, eczema

Bottom Line:

Acetaminophen is neither the safest drug in the pharmacy nor the most dangerous. Like any medication, APAP has benefits and risks. It can ease a headache, lower a fever or ease pain, whether sold as Tylenol or house brand acetaminophen. But it can also cause side effects. People should never take this drug for granted, even though it has been around for a very long time. The fact that it took the FDA more than 50 years to discover the problem with dangerous skin reactions should alert you to the potential risks. Use it when you need it, but be sure to understand the possible hazards.

If you are interested in non-drug ways to control pain and inflammation, you may wish to consult our book, The People’s Pharmacy Quick & Handy Home Remedies. You will learn about anti-inflammatory foods and herbs that are far less likely to raise blood pressure, affect the liver or damage the skin.


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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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I was directed to this site after querying as to what pain meds are safest for ‘F Fib patients. However, I find no explicit answers; do you?

This information was really needed and appreciated.

I had a spinal reconstruction 7 years ago and have been taking hydrocodone 7.5 with 500 mg of acetaminophen daily since, which pretty much controls the leg pain from residual peripheral neuropathy. Up until some months ago, the dosage of acetaminophen was 375 mg., but then the FDA approved the higher dose, apparently with no alternative (but an increase in price!!).
I am not concerned, at age 77, of becoming addicted from the sm. amt of hydrocodone, but I sure am concerned about developing liver disease and other serious side effects of acetaminophen! WHAT WAS THE FDA THINKING??? I’ve known since the 1980’s when I worked with alcoholics, that acetaminophen was poison to the liver and an absolute no-no. But it’s ok for everyone else and especially for children who are given it since infancy?????

I have taken OTC pain relievers such as Excedrin that contain acetaminophen pretty much everyday for the last 30+ years. I honestly think I am addicted to the caffeine in them – I get headaches when I don’t take them. After reading this article, I am afraid my liver may be severely damaged (I am also a recovering alcoholic – sober for 3 months). Are there tests that can determine liver function?

I’ve been taking Tylenol for years and every day. But alternate with other pain relievers. I think it drys out the skin and can depress you, if you take it continuously. It also makes me sleepy, so sleepy that I don’t want to get out of my chair. like all of your information. Can Tylenol and other pain relievers damage you nerves? thank you.

How would one know if his/her kidneys were starting to have problems? Liver either, for that matter. I do take Tylenol as I have Atrial fibrillation and NSAIDS are said to be a major risk factor for AFib. I take maybe 650 mg per day, but thankfully only about 3 days per week.
The only thing I’ve noticed: my trips to the bathroom have been increasing slightly. Could damaged kidneys affect one’s bladder in such a way as to cause increased urgency or frequency?
Peoples Pharmacy response: The best way to track kidney function is with a blood test your doctor could administer. We certainly hope that your kidneys are doing fine.

My 10 year old daughter takes regular strength tylenol because ibuprofin upsets her stomach. What else can we do for fevers or “boo-boos”?

Response to Maria. Curcumin won’t do anything for pain, as far as I know, but it is the most powerful of anti-cancer substances and is also good for blood pressure. I have taken it daily for several years. It is contained in the Indian spice, turmeric. The latter is a wild root crop and is one of the cheapest spices around. Buy it by the quarter pound from a spice shop as it is so cheap that adulteration is not a credible risk. I take it mixed in equal parts of cinnamon (for blood pressure and anti-type 2 diabetes) and powdered cloves, a scant teaspoonful of the mixture daily. I claim no qualifications other than the fact that I read People’s Pharmacy weekly and that a couple of weeks short of my 78th birthday I have not had occasion to consult a G.P. or other medic for roughly fifteen years. Good luck.

The rash is disturbing, but I have become alarmed by the number of people who are being diagnosed with liver issues — including my 30-year-old son. We have been taking this drug as a safe alternative to aspirin without paying attention. This should be a wake-up call.

After my open heart surgery to replace a calcified aortic valve, I was instructed to take the 325 mg aspirin as opposed to the 81mg. Is this going to affect my kidneys/liver?

Have decided to stop taking Ibuprofen for various joint pains. I was taking 2 per day. I wondered if SAM-e 200 mg would be a substitute. On the box it says, If adverse reactions occur to stop use, but it doesn’t say what the adverse reactions would be.
I notice that Mannitol is an ingredient, and I remember that I have digestive difficulty with that.

I myself have never been able to use tylenol. Any thing of that name has always made me feel worse when I took it, one or two times, years ago, and have not knowingly taken it since. But since there are so many drugs with tylenol in them, I may have, but not to a great extent. Good to know this, as I am alerting my two granddaughters who have young children. many thanks.

I did not know that it could raise blood pressure! My kidney function is declining quickly and I fight to keep my blood pressure under control. I was told to not use NSAIDs, including aspirin, for pain because they are “poison to your kidneys.”
I had a long round of gout and took acetaminophen nearly every day for several weeks. I noticed my blood pressure was higher than it had been, but thought it was due to the pain. Then I see that acetaminophen can also cause kidney damage – just what I need. :(

What is considered “regular” use of Tylenol? Once a day, twice a day, or 3 times daily (as recommended as a maximum)?

I receive news emails from MedPages so read the alert several days ago. I usually only take aspirin or APAP when absolutely needed, and then in rotation. I also do not drink as I am aware of the problems that can cause.
A little over a week ago I had severe headaches so I used aspirin the first day, then APAP on the second (along with other non-chemical options). The headache ended but I made a mental note when I read the article to avoid acetaminophen in the future.
Saturday morning I woke up and when I went to wash my face I found a rash. I didn’t immediately think of the article as I have reactions to some chemicals in food (no matter how well I read the label, not everything is listed!). So I went into ‘detoxify mode’, taking extra vitamin C, etc., what usually works. I went out shopping and when I came home I had expected my face to look better. It didn’t–and there were bumps and redness now on my neck and other spots on my face.
I went back to the article and then did my own research about AGEP. I wasn’t worried about the ‘Acute’ part of it but wanted to know more about the “GEP” part. Sunday morning, rash still in place, I went on the offensive.
Since it is the liver which detoxifies what goes through our body it made sense that I should do what I could to help the liver, since it obviously wasn’t working well.
It is now early Monday and I have no new breakouts, the redness is much less and while the breakout/redness is said to continue for over a week or more, I will continue working on good liver health well into the future (no pun intended..).
What I also found was that AGEP is usually the result of antibiotic use which is very frightening…and a very good reason why use of antibiotics should be for definite need and not ‘just in case’.
Phase 1 seems to be what happened with me. The other phases are more complex…and more frightening.
I also looked into what acetaminophen is made from. Coal Tar or Crude oil by-products…including phenol.
I also became concerned because a very, very large volume of the acetaminophen raw product is produced in China (and offering up to 100,000 tons per year to individual buyers) and I remember the problems with other chemicals from China which were found to be contaminated. If acetaminophen creates/provides pathways out of the gut and into other areas of the body, then what might contaminants do?
I’m sure you have articles about the liver and how to keep it healthy or to help heal it. I hope you will make those links available for all your readers who already know the benefits of taking charge of their own health instead of waiting for doctors to (maybe) come up with answers.
Thank you for the great service you have done and are doing for all of us.

I have had a chronic back condition that I have journeyed with for 30+ years.
I have had 3 major surgeries in the last few years – which have allowed me to return to work. I am taking a med with 325 APAP 2 or 3x/day. I haves asked to eliminate the APAP, to little avail. How and where might I locate the alternate Rx to have a serious chat with pain med folks? I started with salis acid and then APAP where I switched every year, until 6 years ago, when aging caught up with things.

My aunt started suffering at a early age (50) of rheumatoid arthritis and her doctor prescribed Tylenol for pain, but was never told not to take more than required. So when she passed away at age 85, she was already had severe damage to her liver and kidney’s.

I think this alert is un-necessarily alarmist. This side effect is quite rare. While I am glad it’s being exposed as a possibility, I think it should be put into perspective.
Acetaminophen is a very useful drug, probably the safest for most people dealing with pain or fever. People without noticeable side effects should not be frightened away from the occasional use of this medicine. Life style changes are all well and good, as are herbal and anti-inflamatory foods, but sometimes immediate relief is needed.
Thanks for the comment. The key phrase is “occasional use.” As long as people do not use the maximum dose daily for days, weeks or months on end, there should be relatively little risk. But as mentioned in our article, most folks do not bother to read the label. Did you know, for example, the the label on Tylenol states quite clearly:
“Stop use and ask a doctor if pain gets worse OR LASTS MORE THAN 10 DAYS.”
People with arthritis or chronic back problems almost assuredly have pain that lasts more than 10 days. They should not be taking Tylenol (or acetaminophen) beyond 10 days without medical supervision. How much do you want to bet that millions ignore that admonition.

In 1979 I started working in a auto assemble factory. I was on different jobs, standing on cement floors 8 to10 hours a day. I was in my late 20s, but everyday there was more joint pain. I was taking tylenol everyday, several times a day. I just wanted the pain to stop so that I could continue working. In 2009 I retired, I have lost hearing in my right ear. I think my hearing loss was from the tylenol.
you know a vet will tell you that you can NEVER give your dog tylenol.

Thank you for caring!

So, please, what are some alternatives? NSAIDs are just as bad and probably worse. Recently, I read an article about curcumin (in another newsletter published by a M.D. who also has his own line of supplements). However, when I contacted the newsletter about purchasing curcumin, I was told that they didn’t sell it. Are there safer alternatives for headache, menstrual cramps and joint pain and do some products work better for certain types of pain?

I’m a good “case study” because I never took any meds that I didn’t absolutely have to take which was usually ordinary antibiotics during ordinary strep throats, etc. I absolutely hate taking ANY meds whatsoever so I only took Tylenol each month (every month with the exception of my one pregnancy) for 30 years for menstrual cramps. I never smoked. I never drink alcohol. Never put anything else in my body; the worse thing I did do what drink soda-Coke for 30 yrs.; I started as a teen and now I’m 51. Soda is toxic.

I took Tylenol for approx. 30 years every month for menstrual cramps. I only took the absolute minimum each month and never beyond the maximum. I never take any other meds at all other than antibiotics throughout those years whenever I got sick just like everyone else. Does this mean I could have possibly damaged some internal organs doing this?

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