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Paracetamol chemically named N-acetyl-p-aminophenol, is a widely used over-the-counter analgesic (pain reliever) and antipyretic (fever reducer).Acetaminophen is the name adopted for this pharmacologic agent in the U.S. (USAN) and Japan; paracetamol is approved in a variety of international venues (INN, AAN, BAN, etc.).Common trade names in English-speaking markets are Tylenol and Panadol.
While generally safe for use at recommended doses, even small overdoses can be fatal. Compared to other over-the-counter pain relievers, paracetamol is significantly more toxic in overdose but may be less toxic when used chronically at recommended doses.Paracetamol is the active metabolite of phenacetin and acetanilide, both once popular as analgesics and antipyretics in their own right.However, unlike phenacetin, acetanilide and their combinations, paracetamol is not considered carcinogenic at therapeutic doses
Adverse effects
In recommended doses and for a limited course of treatment, the side effects of paracetamol are mild to non-existent.
Liver damage
Acute overdoses of paracetamol can cause potentially fatal liver damage. According to the US Food and Drug Administration, "Acetaminophen can cause serious liver damage if more than directed is used." and in 2011 the FDA required manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury[
Skin reactions
On August 2, 2013, the U.S. Food and Drug Administration (FDA) issued a new warning about paracetamol. It stated that the drug could cause rare, and possibly fatal, skin reactions, such as Stevens–Johnson syndrome and toxic epidermal necrolysis. Prescription-strength products will be required to carry a warning label about skin reactions, and the FDA has urged manufacturers to do the same with over-the-counter products.
Asthma
There is an association between paracetamol use and asthma but the weight of evidence of the collected studies strongly suggests that the association reflects various forms of bias, the most prominent of which is confounding by indication.The majority of the evidence does not support a causal role.
As of 2014, the American Academy of Pediatrics and the National Institute for Health and Care Excellence (NICE) continue to recommend paracetamol for pain and discomfort in children,but some experts have recommended that paracetamol use by children with asthma, or at risk for asthma, should be avoided.
Other factors
In contrast to aspirin, paracetamol does not prevent blood from clotting (it is not an antithrombotic), and thus may be used in patients where failure of blood coagulation is a concern; and it does not cause gastric irritation.However, paracetamol does not help reduce inflammation, while aspirin does.Compared to ibuprofen—whose side effects may include diarrhea, vomiting and abdominal pain—paracetamol has fewer adverse gastrointestinal effects.
Reactions
4-Aminophenol may be obtained by the amide hydrolysis of paracetamol. 4-Aminophenol prepared this way, and related to the commercially available Metol, has been used as a developer in photography by hobbyists.This reaction is also used to determine paracetamol in urine samples: After hydrolysis with hydrochloric acid, 4-aminophenol reacts in ammonia solution with a phenol derivate, e.g. salicylic acid, to form an indophenol dye under oxidization by air.
Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. People with liver problems and children should take less acetaminophen. Ask your doctor or pharmacist how much acetaminophen is safe to take.
Do not use with any other drug containing acetaminophen. Acetaminophen is in many nonprescription and prescription medications (such as pain/fever drugs or cough-and-cold products). Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure.
Get medical help right away if you take too much acetaminophen (overdose), even if you feel well. Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, and dark urine.
Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol.
This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.
How to use Acetaminophen Pain Relief
Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.
There are many brands and forms of acetaminophen available. Read the dosing instructions carefully for each product because the amount of acetaminophen may be different between products. Do not take more acetaminophen than recommended. (See also Warning section.)
If you are giving acetaminophen to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.
For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.
For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.
Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.
For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.
Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.
Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.
Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.
This drug usually has no side effects. If you have any unusual effects, contact your doctor or pharmacist promptly.
If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Before taking acetaminophen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this product, tell your doctor or pharmacist your medical history, especially of: liver disease, regular use/abuse of alcohol.
Liquid products, chewable tablets, or dissolving/effervescent tablets may contain sugar or aspartame. Caution is advised if you have diabetes, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. If you have any of these conditions, ask your doctor or pharmacist about using these products safely.
Tell your doctor if you are pregnant before using this medication.
Acetaminophen passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: "blood thinners" (such as warfarin), isoniazid, ketoconazole.
This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If overdose is suspected, contact a poison control center or emergency room immediately.Symptoms of overdose may include: nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, dark urine.
Notes
Acetaminophen does not cause the stomach and intestinal ulcers that NSAIDs such as aspirin, ibuprofen, and naproxen may cause. However, acetaminophen does not reduce swelling (inflammation) like the NSAIDs do. Consult your doctor for more details and to see which medication might be right for you.
Missed Dose
If you are taking this medication on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Storage
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised May 2014. Copyright(c) 2014 First Databank, Inc.
