Tylenol (Acetaminophen) - Summary

TYLENOL SUMMARY

Each Regular Strength TYLENOL® Tablet contains acetaminophen 325 mg. Each Extra Strength TYLENOL® Gelcap, Geltab, Caplet, or Tablet contains acetaminophen 500 mg. Extra Strength TYLENOL® Adult Liquid is alcohol-free and each 15 mL (1/2 fl oz or one tablespoonful) contains 500 mg acetaminophen. Each TYLENOL® Arthritis Pain Extended Relief Caplet and each TYLENOL® 8 Hour Extended Release Geltab/caplet contains acetaminophen 650 mg.

Regular Strength TYLENOL® Tablets, Extra Strength TYLENOL® Gelcaps, Geltabs, Caplets, or Tablets: temporarily relieves minor aches and pains due to:

• headache · muscular aches · backache · arthritis
• the common cold · toothache · menstrual cramps

• temporarily reduces fever

Extra Strength TYLENOL® Adult Liquid: temporarily relieves minor aches and pains due to:

• headache · muscular aches · backache · arthritis
• the common cold · toothache · menstrual cramps
• reduces fever

TYLENOL® Arthritis Pain Extended Release Geltabs/Caplets: temporarily relieves minor aches and pains due to:

• arthritis · the common cold · headache · toothache
• muscular aches · backache · menstrual cramps

TYLENOL® 8 Hour Extended Release Geltabs/Caplets: temporarily relieves minor aches and pains due to:

• muscular aches · backache · headache · toothache · the common cold
• menstrual cramps · minor pain of arthritis
• temporarily reduces fever

See all Tylenol indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Tylenol (Acetaminophen)

Tylenol Overdose Can Be Deadly for a Child
Source: MedicineNet Poison Control Centers Specialty [2012.06.11]
Title: Tylenol Overdose Can Be Deadly for a Child
Category: Health News
Created: 6/8/2012 6:05:00 PM
Last Editorial Review: 6/11/2012 12:00:00 AM

FDA: Manufacturing Problems Led to Tylenol Recall
Source: MedicineNet cetirizine Specialty [2010.05.05]
Title: FDA: Manufacturing Problems Led to Tylenol Recall
Category: Health News
Created: 5/5/2010 10:21:00 AM
Last Editorial Review: 5/5/2010 10:21:13 AM

Recall of Kids' Tylenol, Motrin, Zyrtec, Benadryl
Source: MedicineNet cetirizine Specialty [2010.05.03]
Title: Recall of Kids' Tylenol, Motrin, Zyrtec, Benadryl
Category: Health News
Created: 5/3/2010 9:35:00 AM
Last Editorial Review: 5/3/2010 9:35:18 AM

Recall of More Hydrocodone-Acetaminophen Tablets
Source: MedicineNet Product Recalls Home Page Specialty [2012.12.27]
Title: Recall of More Hydrocodone-Acetaminophen Tablets
Category: Health News
Created: 12/27/2012 11:00:00 AM
Last Editorial Review: 12/27/2012 12:00:00 AM

FDA Warns of Acetaminophen in Prescription Pain Drugs
Source: MedicineNet tramadol Specialty [2011.01.14]
Title: FDA Warns of Acetaminophen in Prescription Pain Drugs
Category: Health News
Created: 1/14/2011 11:00:00 AM
Last Editorial Review: 1/14/2011 12:00:00 AM

more news >>

Published Studies Related to Tylenol (Acetaminophen)

Infant sleep after immunization: randomized controlled trial of prophylactic acetaminophen. [2011.12]
OBJECTIVE: To determine the effects of acetaminophen and axillary temperature responses on infant sleep duration after immunization... CONCLUSIONS: If further research confirms the relationship between time of day of vaccine administration, increased sleep duration after immunization, and antibody responses, then our findings suggest that afternoon immunizations should be recommended to facilitate increased sleep in the 24 hours after immunization, regardless of acetaminophen administration.

A prospective randomized study to evaluate the antipyretic effect of the combination of acetaminophen and Ibuprofen in neurological ICU patients. [2011.12]
BACKGROUND: To compare the antipyretic effect of simultaneously administered acetaminophen (APAP) plus ibuprofen (IBU) to either APAP or IBU alone in critically ill febrile neurological and neurosurgical patients... CONCLUSION: The combination of IBU and APAP produces significantly greater fever control than APAP alone, with trends favoring the combination over IBU alone and IBU over APAP alone.

The effects of preoperative intravenous acetaminophen in patients undergoing abdominal hysterectomy. [2011.12]
PURPOSE: Although intravenous acetaminophen is commonly used for the management of postoperative pain, very limited evidence supports the usefulness of preoperative administration. The aim of this study was to determine the analgesic effect of preoperative acetaminophen on opioid consumption, pain scores, and side effects in patients receiving an elective abdominal hysterectomy... CONCLUSIONS: Premedication with acetaminophen reduced hydromorphone consumption and opioid-related side effect in patients undergoing abdominal hysterectomy, but did not significantly reduce pain intensity.

UGT1A6 and UGT2B15 polymorphisms and acetaminophen conjugation in response to a randomized, controlled diet of select fruits and vegetables. [2011.09]
Acetaminophen (APAP) glucuronidation is thought to occur mainly by UDP-glucuronosyltransferases (UGT) in the UGT1A family... Selected F&V known to affect UGT activity led to greater glucuronidation and less sulfation.

The effect of the once-daily human glucagon-like peptide 1 analog liraglutide on the pharmacokinetics of acetaminophen. [2011.08]
INTRODUCTION: Acetaminophen is a commonly used analgesic and antipyretic drug, and is frequently used to study gastric emptying. Due to its high permeability and high solubility, acetaminophen can be used as a pharmacologic model for medications with similar characteristics. The objective of this study was to assess the effect of liraglutide on the pharmacokinetics (PK) of acetaminophen in patients with type 2 diabetes... CONCLUSION: The overall exposure of acetaminophen following a 1 g dose was comparable for subjects taking liraglutide or placebo, and the clinical impact of the lower C(max) and delay in absorption of acetaminophen was considered to be transient and small, and without clinical relevance. No adjustment for acetaminophen is recommended when used concomitantly with liraglutide.

more studies >>

Clinical Trials Related to Tylenol (Acetaminophen)

Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days [Completed]
Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver. The protein-acetaminophen product is called an "adduct". After a large acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of adducts are formed. However, we have found that lower levels may be formed even when people take recommended doses. The purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.

A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery [Completed]
Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen.

Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument.

The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day).

This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free.

The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.

Acetaminophen-Protein Adduct Resolution [Recruiting]
The purpose of this study is to better understand the pharmacokinetics of acetaminophen and further clinical interpretations of laboratory results that confirm the presence of acetaminophen-cys adducts. This study will determine how long adducts persist in serum after a therapeutic course of acetaminophen as taken in a previous study (COMIRB 06-1265). Subjects will be asked to complete three study visits, each three days apart, following termination of COMIRB 06-1265. Each study visit will include collection of blood samples for batch testing of aminotransferase, serum acetaminophen and protein adducts. No interventions are planned.

Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates [Recruiting]
The purpose of this study is triple, i. e. document single dose pharmacokinetics and

- dynamics of intravenous paracetamol in preterm and term neonates after a loading dose (20

mg/kg iv bolus paracetamol), document multiple dose pharmacokinetics and - dynamics of

intravenous paracetamol in preterm and term neonates, based on the daily doses routinely used within the neonatal intensive care unit and as reported in literature. Finally, document safety of single and repeated dose of intravenous paracetamol in preterm and term neonates.

Aminotransferase Trends During Prolonged Acetaminophen Dosing [Recruiting]
The objective of this study is to monitor liver function tests (blood levels of an indicator of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen compared to people taking placebo for 16 to 40 days. Those people that continue to have normal liver tests after 16 days will have completed their part of the study. People that develop abnormal liver function tests will continue taking acetaminophen or placebo, and have their liver tests monitored closely for up to an additional 24 days. This is to (1) make sure these tests return to normal and (2) determine when these tests return to normal while still taking acetaminophen or placebo. If at any time the liver tests indicate anything more than a minor increase, you would be immediately told to stop taking the study drug.

Secondary objective is to determine the proportion of subjects that have detectable acetaminophen-protein adducts after daily dosing.

more trials >>

Reports of Suspected Tylenol (Acetaminophen) Side Effects

Drug Ineffective (27),  Anxiety (12),  Weight Increased (11),  Acute Hepatic Failure (9),  Toxic Epidermal Necrolysis (8),  Urticaria (7),  Headache (7),  Overdose (7),  Renal Failure Acute (7),  Suicide Attempt (7), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Tylenol review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		headache
Dosage & duration:		400mg taken 1 for the period of 1 dose
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I believe that there are multiple treatment benefits of Taking Tylenol for my headache. Tylenol is safe, inexpensive, and does not require a physicians prescription. Additionally, it is available almost everywhere and therefor is convenient.
Side effects:		There were no treatment side effects from me taking Tylenol for my headache.
Comments:		There are no deatails to report. My headache was gone within 30 minutes.

Tylenol review by 21 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Headache
Dosage & duration:		2 pills taken 2-3 times per month for the period of 4 months
Other conditions:		Allergies
Other drugs taken:		Loratadine
		Reported Results
Benefits:		Actually symptoms dissapeared almost within 15-20 min after taking medication, making it easy to continue with your normal day activities, even if that includes gym or an outdoor activity.
Side effects:		Sometimes I felt nausea, except that, there was no other significant side effect.
Comments:		Two pills everytime I had headache, avoiding to take more than 4 pills in one day.

Tylenol review by 42 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		pain
Dosage & duration:		250 mg. taken 2 every 4 hours for the period of 3 doses
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Little if any relief from headache.
Side effects:		Patient experienced severe nausea accompanied by moderate lower right abdominal pain.
Comments:		Patient experienced severe headache accompanied by sensitivity to light. Packing information claimed relief of headache as a suggested usage. Patient purchased in reliance on packaging information. After administration of the prescribed dosage over a period of twelve hours, little or no relief was noticed.