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Acetaminophen Safety: Be Cautious But Not Afraid

Tylenol to spell out painkiller’s risks on cap

Cold, cough, and flu season is a good time to revisit the risks of acetaminophenthe pain and fever reliever in Tylenol and many other over-the-counter medications. Billions of doses of acetaminophen are consumed safely every year, but deaths still occur from accidental overdoses and thousands of people end up in the emergency room. More than 600 products contain acetaminophen, and inadvertently combining them can nudge you into the red zone.

“People don’t realize that these doses all add up, and before you know it you’ve exceeded the recommended dose of acetaminophen,” says Dr. Melisa Lai Becker, instructor in medicine at Harvard Medical School and a specialist in emergency medicine and toxicology at Harvard-affiliated Cambridge Health Alliance.

How Should This Medicine Be Used

Acetaminophen comes as a tablet, chewable tablet, capsule, suspension or solution , extended-release tablet, and orally disintegrating tablet , to take by mouth, with or without food. Acetaminophen is available without a prescription, but your doctor may prescribe acetaminophen to treat certain conditions. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

If you are giving acetaminophen to your child, read the package label carefully to make sure that it is the right product for the age of the child. Do not give children acetaminophen products that are made for adults. Some products for adults and older children may contain too much acetaminophen for a younger child. Check the package label to find out how much medication the child needs. If you know how much your child weighs, give the dose that matches that weight on the chart. If you don’t know your child’s weight, give the dose that matches your child’s age. Ask your child’s doctor if you don’t know how much medication to give your child.

Swallow the extended-release tablets whole do not split, chew, crush, or dissolve them.

Place the orally disintegrating tablet in your mouth and allow to dissolve or chew it before swallowing.

Acetaminophen Toxicity And Overdose

Acetaminophen toxicity, also known as acetaminophen overdose, is a well-known cause of acute liver failure. A person may knowingly take more of the drug than is safe, or they may accidently consume too much acetaminophen, which can happen when taking multiple cold medicines that each contain acetaminophen.

Whether intentional or accidental, the symptoms and treatment of liver damage are the same. Supporting measures, such as IV fluids and anti-nausea medication, can help someone recover from acetaminophen toxicity. Most people do recover from the effects of an acetaminophen overdose. In rare cases, however, toxicity can progress to liver failure, which would require a liver transplant. Death can also occur following an acetaminophen overdose if not treated promptly.

As the mostly commonly used drug in the United States, acetaminophen is hard for many people to imagine as a substance of abuse. Used for everyday treatment of common aches and pains, the over-the-counter accessibility of the drug makes it a prime candidate for self-medication. When used as directed, acetaminophen is safe and unlikely to cause adverse side effects. When misused or overused, however, acetaminophen toxicity can quickly lead to liver damage.

Liver damage associated with acetaminophen use sends thousand of Americans to the hospital each year. The side effects of acetaminophen use are rarely permanent, but if not addressed appropriately, they can lead to serious liver injury and even death.

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Is Acetaminophen A Nsaid

Acetaminophen belongs to two classes of drugs: analgesics and antipyretics . It works by blocking the production of pain-inducing molecules in the brain, according to Tufts University. It also tells the brain to cool off the body during fever.

Acetaminophen is not a nonsteroidal anti-inflammatory drug , a class of drugs that includes ibuprofen and aspirin. NSAIDs can treat pain and fever and also reduce inflammation. In contrast,acetaminophen does not reduce inflammation, according to Harvard Medical School. But while NSAIDs can irritate the stomach and intestinal lining, acetaminophen does not.

How Should I Use This Medication

5 Pack Tylenol Extra Strength 500Mg Pain Fever Reducer 100 Tablets Each ...

Always read the product label and follow the instructions. Acetaminophen is used in many non-prescription and prescription medications, including products for cough and cold, pain relief, and headache pain.

Take the smallest amount of medication that works for you. Never take more than the maximum daily dose.

Take only one product that contains acetaminophen at a time. Acetaminophen is in many products and you could accidentally take too much if you’re using more than one product at the same time.

Acetaminophen can be used by all age groups in recommended doses.

Children : The dose of acetaminophen for children is based on body size. Usually, it is calculated as 10 mg to 15 mg per kilogram of body weight, every 4 to 6 hours. No more than 65 mg/kg should be given in a 24-hour period. Children should not take more than 5 doses in 24 hours unless advised by a doctor. For children under 6 months of age, consult a doctor.

Children’s liquid medications should be given using a calibrated dosing device, such as an oral syringe. This ensures that you are giving your child the right amount. Some formulations of liquid acetaminophen contain different concentrations of acetaminophen. Pay careful attention to the concentration on the label and the calculated dose volume.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

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What Other Medications May Interact With Tylenol

Tell your healthcare provider about all of the medicines you take, including prescription and OTC medicines, and vitamins or supplements.

Tylenol should not be used in combination with topical lidocaine or topical prilocaine in infants less than 12 months old. In adults and children older than 12 months, if the combination must be used together, the lowest doses and shortest treatment time should be used.

The following medications can increase the risk of toxicity when taken with Tylenol:

  • Barbiturates such as phenobarbital or pentobarbital

If taking any of the above medications, talk to your healthcare provider before using Tylenol. You may need to avoid the medication or use a lower dose.

Other interactions can occur with:

  • A blood thinner called : This interaction can increase the risk of bleeding, which may be life-threatening.
  • Other medications containing acetaminophen: Combining acetaminophen from more than one medication can increase the risk of overdose and toxicity.
  • NSAIDs such as aspirin, Celebrex ,Mobic , or Advil and Motrin, especially with long-term treatment: Taking these with Tylenol can increase the risk of kidney problems.

Other drug interactions may occur with Tylenol. Consult your healthcare provider for a complete list of drug interactions.

What Should I Do If I Forget A Dose

This medication is usually taken as needed. If your doctor has told you to take acetaminophen regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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How Acetaminophen Causes Liver Failure

The drug is primarily metabolized, or broken down, in the liver. Under normal conditions, the liver eliminates acetaminophen and its byproducts, sulfate and glucuronide, without a problem.

P-450 processes these byproducts but creates a toxic compound called NAPQI. Too much NAPQI causes liver damage.

While some cases of Tylenol poisoning are purposeful, many are not. Acetaminophen is a common ingredient in many medications, including a number of narcotic painkillers and flu and cold medications sold over the counter. As a result, people sometimes take far more than the maximum daily dose without even realizing it.

We see unintentional overdoses when people combine multiple products with acetaminophen, such as Nyquil and Tylenol.

Medically Reviewed

Board-certified physicians medically review Drugwatch content to ensure its accuracy and quality.

Drugwatch partners with Physicians Review Network Inc. to enlist specialists. PRN is a nationally recognized leader in providing independent medical reviews.

Reviewer specialties include internal medicine, gastroenterology, oncology, orthopedic surgery and psychiatry.

Are There Any Other Precautions Or Warnings For This Medication

Tylenol’s bizarre side effect

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.


Health Canada has issued new restrictions concerning the use of acetaminophen. To read the full Health Canada Advisory, visit Health Canada’s web site at

Previous advisories on acetaminophen were issued on and .

Alcohol: Chronic excessive use of alcohol may increase the risk of liver damage due to acetaminophen, even when acetaminophen is used at normal doses. If you drink 3 or more alcoholic beverages per day your risk of severe or possibly fatal liver damage is increased.

Avoiding overdose: Acetaminophen is a frequent cause of accidental poisoning for infants and children. Keep the medication out of the reach of children, use an oral syringe to measure the dose, read the package carefully, and consult your pharmacist or doctor to confirm the best dose for your child.

Contact your doctor immediately if you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin.

Pregnancy: Acetaminophen is reported to be safe for short-term use in pregnancy at recommended doses.

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Can I Use Acetaminophen Or Ibuprofen With Alcohol

No. Drinking alcohol with acetaminophen or ibuprofen can increase the risk of adverse effects. Alcohol can disrupt the lining of the stomach and intestines, increasing the risk of stomach ulcers. Drinking alcohol may increase the risk of stomach ulcers from acetaminophen or ibuprofen. In addition, heavy, chronic alcohol use can increase the risk of liver damage. Combining alcohol with acetaminophen or ibuprofen should be avoided.

Overdose Signs And Acute Liver Failure

The initial signs and symptoms of an overdose include diarrhea, sweating and a loss of appetite. Vomiting, stomach cramps and abdominal pain are common. Because the liver is located in the upper right quadrant of the abdomen, a person may experience pain, swelling and tenderness in that region.

There are four distinct phases of Tylenol-induced poisoning. It is critical to seek help immediately if you experience any of the following symptoms because complete liver failure can occur within 72 hours of ingesting the drug.

Phase I
This occurs in the first 24 hours after an overdose. People usually experience nausea, tiredness , anorexia, vomiting, paleness and excessive sweating .
Phase II
In the next 18 to 72 hours, patients may develop right-upper quadrant abdominal pain. Nausea and vomiting continue. In addition, fast heartbeat and low blood pressure may be present.
Phase III
This phase begins about 72 to 96 hours after ingesting the drug. Symptoms of liver failure or liver damage include jaundice, hypoglycemia , bleeding and loss of brain function from toxins. Multiple organ failure and death may also occur at this stage.
Phase IV
Patients who survive Phase III spend this time in recovery. This phase lasts four days to three weeks. Symptoms resolve during this period.

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Can Acetaminophen Cause Liver Damage

In the United States, acetaminophen is the most common cause of acute liver failure, according to the Mayo Clinic.

In January of 2011, the FDA urged health care professionals to stop prescribing combination drug products that contain more than 325 milligrams of acetaminophen per dose to reduce the risk of liver damage, according to the American Society of Anesthesiologists. By 2014, the agency announced that all manufacturers of prescription combination drug products with acetaminophen had stopped making products with more than 325 mg of acetaminophen. Though the risk of liver damage from overdose of acetaminophen has long-been known, this most recent action is targeted at reducing the number of people who overdose by unknowingly taking too many medications that contain acetaminophen, the FDA said.

When the liver breaks down acetaminophen, it produces a toxic metabolite called NAPQI. But when people take the recommended dose of acetaminophen, only a small amount of NAPQI is produced, and the liver is able to clear this metabolite. However, when people take an overdose, this clearance pathway becomes overwhelmed and NAPQI damages the liver, according to the Utah Poison Control Center.

Patients should be sure to tell their doctor if they have any history of liver problems or drink more than two alcoholic beverages per day.

Acetaminophen Safe Dosage Basics

How Long Does Tylenol Pm Take To Work

Acetaminophen controls pain and fever but does not reduce inflammation, as does aspirin and the other widely consumed nonsteroidal anti-inflammatory drugs ibuprofen and naproxen . But unlike NSAIDs, acetaminophen does not irritate the stomach and intestinal lining. That means a person who cannot tolerate NSAIDs can still take acetaminophen. It’s an important drug for controlling chronic pain in older adults.

The hitch is that acetaminophen also has a narrower window of safety compared with ibuprofen and naproxen. NSAIDs can make you sick, too, but it takes a larger amount to reach a dangerous overdose. Taking too much acetaminophen can damage the liver, sometimes leading to a liver transplant or death.

The body breaks down most of the acetaminophen in a normal dose and eliminates it in the urine. But some of the drug is converted into a byproduct that is toxic to the liver. If you take too muchall at once or over a period of daysmore toxin can build up than the body can handle.

For the average healthy adult, the generally recommended maximum daily dose is no more than 4,000 milligrams from all sources. But in some people, doses close to the 4,000 mg daily limit for adults could still be toxic to the liver. It’s safest to take only what you need, and to not exceed 3,000 mg a day whenever possible, especially if you use acetaminophen often.

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**please Note We Are No Longer Accepting Tylenol Cases**

Life-threatening Tylenol side effects remain a serious public health problem, even as Tylenol lawsuits increase in number. The Sanders Firm is committed to helping victims of these side effects obtain compensation for their injuries. Our veteran product liability attorneys offer free, no-obligation consultations to those harmed by Tylenol use. We can explain your legal options, give you an honest assessment as to the strength of your case, and help you and your family decide what to do next at this critical and trying time.

Acetaminophen As A Recreational Drug

Recent studies suggest that acetaminophen isnt addictive and people dont take it to get high. It is, however, an active ingredient in many painkillers, such as Vicodin or Percocet, which are abused for their highs. It is the acetaminophen contained in these drugs that is often the most damaging.

Overdose from acetaminophen causes about 60,000 people each year to go to the hospital, several hundred of which die from associated liver failure.

Acetaminophen is most commonly misused as a recreational drug in conjunction with other drugs. On its own, acetaminophen is widely accepted to be a safe drug and is easily accessible.

More potent forms of acetaminophen, however, such as Tylenol 3, can only be obtained through a doctors prescription, as it also contains a significant amount of codeine, another painkilling drug. Acetaminophen alone is not particularly habit-forming, but the codeine in Tylenol 3 can lead to dependency.

The codeine in Tylenol 3 can cause feelings of euphoria, which leads some people to misuse the drug. Tylenol 3 has also been shown to enhance the effects of other drugs, such as narcotics, alcohol, general anesthetics, tranquilizers, sedative-hypnotics, and other central nervous system depressants. Combining acetaminophen with any of these drugs increases the risk of experiencing the adverse side effects of each drug.

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What Side Effects Are Possible With This Medication

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • signs of anemia
  • signs of clotting problems
  • signs of kidney problems
  • signs of infection
  • skin rash, hives, or itching
  • symptoms of liver damage:
    • stomach cramps or pain
    • swelling, pain, or tenderness in the upper abdomen or stomach area

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

More About Acetaminophen Pm Extra Strength

Tylenol Creators Release New Medical Warning on Pill Bottles

1. “Product Information. Tylenol Extra Strength PM .” Johnson and Johnson/Merck :

2. Lee WM “Medical progress: drug-induced hepatotoxicity.” N Engl J Med 333 : 1118-27

3. Brown G “Acetaminophen-induced hypotension.” Heart Lung 25 : 137-40

4. Dundar SV, Haznedaroglu IC, Ozcebe OI, Sayinalp N, Celik I, Gursoy M “Agranulocytosis, plasmacytosis, and thrombocytosis followed by a leukemoid reaction due to acute acetaminophen toxicity.” Ann Pharmacother 30 : 762-5

5. Hiruma M, Ishibashi A, Noguchi H, Kawada A “Fixed drug eruption induced by acetaminophen in a 12-year-old girl.” Int J Dermatol 35 : 148-9

6. LopezSerrano MC, Barranco P, MorenoAncillo A “Anaphylactic reaction due to diphenhydramine.” Allergy 53 : 814

7. BenAmitai D, Garty BZ, Halevi A “Toxic epidermal necrolysis associated with acetaminophen ingestion.” Ann Pharmacother 34 : 32-4

8. Pronchik DJ, Sexton JD “Diphenhydramine induced psychosis with therapeutic doses.” Am J Emerg Med 15 : 548-9

9. Richardson GS, Roehrs TA, Rosenthal L, Roth T, Koshorek G “Tolerance to daytime sedative effects of h1 antihistamines.” J Clin Psychopharmacol 22 : 511-5

10. Eguia L, Materson BJ “Acetaminophen-related acute renal failure without fulminant liver failure.” Pharmacotherapy 17 : 363-70

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