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Acetaminophen

Thursday, March 28, 2019

Acetaminophen









Generic Name: acetaminophen (oral) (a SEET a MIN oh fen)
Brand Names: Actamin, Anacin AF, Apra, Bromo Seltzer, Children's Tylenol, Elixsure Fever/Pain, Mapap, Medi-Tabs, Q-Pap, Silapap Childrens, Tactinal, Tempra Quicklets, Tycolene, Tylenol, Vitapap
Acetaminophen is also available in many over-the-counter combination medications with other drugs, including Actifed, Alka-Seltzer Plus Liquid Gels, Cepacol, Contac, Coridicin, Dayquil, Dimetapp, Dristan, Excedrin, Feverall, Liquiprin, Midol, Nyquil, Panadol, Robitussin Singlet, Sinutab, Sudafed, Theraflu, Triaminic, Vanquish, Vicks, and Zicam.
Acetaminophen is also found in many prescription combination drugs, including Butalbital, Endocet, Fioricet, Hycotab, Hydrocet, Hydrocodone bitartrate, Lortab, Percocet, Phenaphen, Sedapap, Tapanol, Tylenol with codeine, Tylox, Ultracet, Vicodin, and Zydone.
Medically reviewed by Kaci Durbin, MD. Last updated on Dec 29, 2018

What is acetaminophen?

Acetaminophen is a pain reliever and a fever reducer.
Acetaminophen is used to treat mild to moderate and pain, to treat moderate to severe pain in conjunction with opiates, or to reduce fever. Common conditions that acetaminophen treats include headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.
Acetaminophen may also be used for purposes not listed in this medication guide. It is typically used orally, but can be given intravenously.

Important information

You should not use this medication if you have severe liver disease.
An overdose of acetaminophen can damage your liver or cause death.
  • Adults and teenagers who weigh at least 110 pounds should not take more than 1000 milligrams (mg) at one time, or more than 4000 mg in 24 hours.
  • Children younger than 12 years old should not take more than 5 doses in 24 hours, using only the number of milligrams per dose that is recommended for the child's weight and age. Use exactly as directed on the label.
Avoid also using other medicines that contain acetaminophen (sometimes abbreviated as APAP), or you could have a fatal overdose.
Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).
Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Before taking this medicine

You should not take acetaminophen if you are allergic to it, or if you have severe liver disease.
Do not take this medicine without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen.
Your doctor will determine whether acetaminophen is safe for you to use during pregnancy. Do not use this medicine without the advice of your doctor if you are pregnant.
Acetaminophen can pass into breast milk. Tell your doctor if you are breast-feeding a baby.
Do not give this medicine to a child younger than 2 years old without the advice of a doctor.

How should I take acetaminophen?

Use acetaminophen exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.
  • Adults and teenagers who weigh at least 110 pounds (50 kilograms): Do not take more than 1000 milligrams (mg) at one time. Do not take more than 4000 mg in 24 hours.
  • Children younger than 12 years old: Do not take more than 5 doses of acetaminophen in 24 hours. Use only the number of milligrams per dose that is recommended for the child's weight and age. Use exactly as directed on the label.
  • Avoid also using other medicines that contain acetaminophen, or you could have a fatal overdose.
If you are treating a child, use a pediatric form of acetaminophen. Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label.
Measure liquid medicinewith the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
Acetaminophen made for infants is available in two different dose concentrations, and each concentration comes with its own medicine dropper or oral syringe. These dosing devices are not equal between the different concentrations. Using the wrong device may cause you to give your child an overdose of acetaminophen. Never mix and match dosing devices between infant formulations of acetaminophen.
You may need to shake the liquid before each use. Follow the directions on the medicine label.
The chewable tablet must be chewed thoroughly before you swallow it.
Make sure your hands are dry when handling the acetaminophen disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
To use the acetaminophen effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.
Stop taking acetaminophen and call your doctor if:
  • you still have a fever after 3 days of use;
  • you still have pain after 7 days of use (or 5 days if treating a child);
  • you have a skin rash, ongoing headache, or any redness or swelling; or
  • if your symptoms get worse, or if you have any new symptoms.
This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using acetaminophen.
Store at room temperature away from heat and moisture.

What happens if I miss a dose?

Since acetaminophen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking acetaminophen?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.
Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Acetaminophen side effects

Get emergency medical help if you have signs of an allergic reaction to acetaminophen: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken this medicine in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.
Stop taking acetaminophen and call your doctor at once if you have:
  • nausea, upper stomach pain, itching, loss of appetite;
  • excessive sweating and severe tiredness;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).
The most common side effects of acetaminophen include:
  • nausea and vomiting;
  • headache; or
  • insomnia
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect acetaminophen?

Other drugs may interact with acetaminophen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use acetaminophen only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

What is acetaminophen?

Acetaminophen is a pain reliever and a fever reducer.
Acetaminophen is used to treat mild to moderate and pain, to treat moderate to severe pain in conjunction with opiates, or to reduce fever. Common conditions that acetaminophen treats include headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.
Acetaminophen may also be used for purposes not listed in this medication guide. It is typically used orally, but can be given intravenously.

Important information

You should not use this medication if you have severe liver disease.
An overdose of acetaminophen can damage your liver or cause death.
  • Adults and teenagers who weigh at least 110 pounds should not take more than 1000 milligrams (mg) at one time, or more than 4000 mg in 24 hours.
  • Children younger than 12 years old should not take more than 5 doses in 24 hours, using only the number of milligrams per dose that is recommended for the child's weight and age. Use exactly as directed on the label.
Avoid also using other medicines that contain acetaminophen (sometimes abbreviated as APAP), or you could have a fatal overdose.
Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).
Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Before taking this medicine

You should not take acetaminophen if you are allergic to it, or if you have severe liver disease.
Do not take this medicine without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen.
Your doctor will determine whether acetaminophen is safe for you to use during pregnancy. Do not use this medicine without the advice of your doctor if you are pregnant.
Acetaminophen can pass into breast milk. Tell your doctor if you are breast-feeding a baby.
Do not give this medicine to a child younger than 2 years old without the advice of a doctor.

How should I take acetaminophen?

Use acetaminophen exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.
  • Adults and teenagers who weigh at least 110 pounds (50 kilograms): Do not take more than 1000 milligrams (mg) at one time. Do not take more than 4000 mg in 24 hours.
  • Children younger than 12 years old: Do not take more than 5 doses of acetaminophen in 24 hours. Use only the number of milligrams per dose that is recommended for the child's weight and age. Use exactly as directed on the label.
  • Avoid also using other medicines that contain acetaminophen, or you could have a fatal overdose.
If you are treating a child, use a pediatric form of acetaminophen. Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label.
Measure liquid medicinewith the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
Acetaminophen made for infants is available in two different dose concentrations, and each concentration comes with its own medicine dropper or oral syringe. These dosing devices are not equal between the different concentrations. Using the wrong device may cause you to give your child an overdose of acetaminophen. Never mix and match dosing devices between infant formulations of acetaminophen.
You may need to shake the liquid before each use. Follow the directions on the medicine label.
The chewable tablet must be chewed thoroughly before you swallow it.
Make sure your hands are dry when handling the acetaminophen disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
To use the acetaminophen effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.
Stop taking acetaminophen and call your doctor if:
  • you still have a fever after 3 days of use;
  • you still have pain after 7 days of use (or 5 days if treating a child);
  • you have a skin rash, ongoing headache, or any redness or swelling; or
  • if your symptoms get worse, or if you have any new symptoms.
This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using acetaminophen.
Store at room temperature away from heat and moisture.

What happens if I miss a dose?

Since acetaminophen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking acetaminophen?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.
Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Acetaminophen side effects

Get emergency medical help if you have signs of an allergic reaction to acetaminophen: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken this medicine in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.
Stop taking acetaminophen and call your doctor at once if you have:
  • nausea, upper stomach pain, itching, loss of appetite;
  • excessive sweating and severe tiredness;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).
The most common side effects of acetaminophen include:
  • nausea and vomiting;
  • headache; or
  • insomnia
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect acetaminophen?

Other drugs may interact with acetaminophen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use acetaminophen only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Acetaminophen Side Effects

More frequently reported side effects include: fever. See below for a comprehensive list of adverse effects.

Along with its needed effects, acetaminophen may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking acetaminophen:

Rare

  • Bloody or black, tarry stools
  • bloody or cloudy urine
  • fever with or without chills (not present before treatment and not caused by the condition being treated)
  • pain in the lower back and/or side (severe and/or sharp)
  • pinpoint red spots on the skin
  • skin rashhives, or itching
  • sore throat (not present before treatment and not caused by the condition being treated)
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden decrease in the amount of urine
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen:

Symptoms of Overdose

  • Diarrhea
  • increased sweating
  • loss of appetite
  • nausea or vomiting
  • stomach cramps or pain
  • swelling, pain, or tenderness in the upper abdomen or stomach area

For Healthcare Professionals

Applies to acetaminophen: compounding powder, intravenous solution, oral capsule, oral granule effervescent, oral liquid, oral powder for reconstitution, oral suspension, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release, rectal suppository

General

In general, acetaminophen is well-tolerated when administered in therapeutic doses. The most commonly reported adverse reactions have included nausea, vomiting, constipation. Injection site pain and injection site reaction have been reported with the IV product.[Ref]

Hepatic

Common (1% to 10%): Increased aspartate aminotransferase
Rare (less than 0.1%): Increased hepatic transaminases
Frequency not reported: Liver failure[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 34%), Vomiting (up to 15%)
Common (1% to 10%): Abdominal pain, diarrhea, constipation, dyspepsia, enlarged abdomen
Frequency not reported: Dry mouth[Ref]

Hypersensitivity

Postmarketing reportsAnaphylaxis, hypersensitivity reactions[Ref]

Hematologic

Common (1% to 10%): Anemia, postoperative hemorrhage
Very rare (less than 0.01%): Thrombocytopenia, leucopenia, neutropenia[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus
Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis
Very rare (less than 0.01%): Pemphigoid reaction, pustular rash, Lyell syndrome[Ref]

Respiratory

Common (1% to 10%): Dyspnea, abnormal breath sounds, pulmonary edema, hypoxia, pleural effusion, stridor, wheezing, coughing[Ref]

Cardiovascular

Common (1% to 10%): Peripheral edema, hypertension, hypotensiontachycardia, chest pain[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, hyperglycemia[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Frequency not reportedDystonia

Musculoskeletal

Common (1% to 10%): Muscle spasms, trismus

Psychiatric

Common (1% to 10%): Insomniaanxiety

Genitourinary

Common (1% to 10%): Oliguria

Local

Common (1% to 10%): Infusion site pain, injection site reactions

Ocular

Common (1% to 10%): Periorbital edema

Other

Common (1% to 10%): Pyrexia, fatigue
Rare (0.01% to 0.1%): Malaise

References

1. "Multum Information Services, Inc. Expert Review Panel"
2. Zimmerman HJ, Maddrey WC "Acetaminophen (paracetamol) hepatotoxicity with regular intake of alcohol: analysis of instances of therapeutic misadventure." Hepatology 22 (1995): 767-73
3. Vitols S "Paracetamol hepatotoxicity at therapeutic doses." J Intern Med 253 (2003): 95-8
4. Gursoy M, Haznedaroglu IC, Celik I, Sayinalp N, Ozcebe OI, Dundar SV "Agranulocytosis, plasmacytosis, and thrombocytosis followed by a leukemoid reaction due to acute acetaminophen toxicity." Ann Pharmacother 30 (1996): 762-5
5. Kurtovic J, Riordan SM "Paracetamol-induced hepatotoxicity at recommended dosage." J Intern Med 253 (2003): 240-3
6. Cheung L, Meyer KC "Acetaminophen poisoning and liver function." N Engl J Med 331 (1994): 1311-2
7. Kumar S, Rex DK "Failure of physicians to recognize acetaminophen hepatotoxicity in chronic alcoholics." Arch Intern Med 151 (1991): 1189-91
8. Rumore MM, Blaiklock RG "Influence of age-dependent pharmacokinetics and metabolism on acetaminophen hepatotoxicity." J Pharm Sci 81 (1992): 203-7
9. McJunkin B, Barwick KW, Little WC, Winfield JB "Fatal massive hepatic necrosis following acetaminophen overdose." JAMA 236 (1976): 1874-5
10. Minton NA, Henry JA, Frankel RJ "Fatal paracetamol poisoning in an epileptic." Hum Toxicol 7 (1988): 33-4
11. Hartleb M "Do thyroid hormones promote hepatotoxicity to acetaminophen?" Am J Gastroenterol 89 (1994): 1269-70
12. Lee WM "Acute liver failure." Am J Med 96 (1994): 3-9
13. Block R, Jankowski JA, Lacoux P, Pennington CR "Does hypothermia protect against the development of hepatitis in paracetamol overdose?" Anaesthesia 47 (1992): 789-91
14. Whitcomb DC, Block GD "Association of acetaminopphen hepatotoxicity with fasting and ethanol use." JAMA 272 (1994): 1845-50
15. Kaysen GA, Pond SM, Roper MH, Menke DJ, Marrama MA "Combined hepatic and renal injury in alcoholics during therapeutic use of acetaminophen." Arch Intern Med 145 (1985): 2019-23
16. Singer AJ, Carracio TR, Mofenson HC "The temporal profile of increased transaminase levels in patients with acetaminophen-induced liver dysfunction." Ann Emerg Med 26 (1995): 49-53
17. Bonkovsky HL "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA 274 (1995): 301
18. Mofenson HC, Caraccio TR, Nawaz H, Steckler G "Acetaminophen induced pancreatitis." Clin Toxicol 29 (1991): 223-30
19. Brotodihardjo AE, Batey RG, Farrell GC, Byth K "Hepatotoxicity from paracetamol self-poisoning in Western Sydney: a continuing challenge." Med J Aust 157 (1992): 382-5
20. Keaton MR "Acute renal failure in an alcoholic during therapeutic acetaminophen ingestion." South Med J 81 (1988): 1163-6
21. Keays R, Harrison PM, Wendon JA, et al "Intravenous acetylcysteine in paracetamol induced fulminant hepatic failure: a prospective controlled trial." BMJ 303 (1991): 1026-9
22. Seeff LB, Cuccherini BA, Zimmerman HJ, Adler E, Benjamin SB "Acetaminophen hepatotoxicity in alcoholics." Ann Intern Med 104 (1986): 399-404
23. Lee WM "Medical progress: drug-induced hepatotoxicity." N Engl J Med 333 (1995): 1118-27
24. Wong V, Daly M, Boon A, Heatley V "Paracetamol and acute biliary pain with cholestasis." Lancet 342 (1993): 869
25. Whitcomb DC "Acetaminophen poisoning and liver function." N Engl J Med 331 (1994): 1311
26. Block R "Liver failure induced by paracetamol." BMJ 306 (1993): 457
27. Cheung L, Potts RG, Meyer KC "Acetaminophen treatment nomogram." N Engl J Med 330 (1994): 1907-8
28. O'Dell JR, Zetterman RK, Burnett DA "Centrilobular hepatic fibrosis following acetaminophen-induced hepatic necrosis in an alcoholic." JAMA 255 (1986): 2636-7
29. Johnson GK, Tolman KG "Chronic liver disease and acetaminophen." Ann Intern Med 87 (1977): 302-4
30. Nelson EB, Temple AR "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA 274 (1995): 301
31. Smilkstein MJ, Douglas Dr, Daya MR "Acetaminophen poisoning and liver function." N Engl J Med 331 (1994): 1310-1
32. Shriner K, Goetz MB "Severe hepatotoxicity in a patient receiving both acetaminophen and zidovudine." Am J Med 93 (1992G

GIVEN INFORMATION IS REFERENCE PURPOSE ONLY YOU MAY CONSULT YOUR DOCTOR FOR MORE INFORMATION