Generic name: acetaminophen
Medically reviewed by Drugs.com. Last updated on Aug 29, 2023.
Note: This document contains side effect information about acetaminophen. Some dosage forms listed on this page may not apply to the brand name Paracetamol.
Applies to acetaminophen: capsule, capsule liquid filled, elixir, liquid, powder, solution, suppository, suspension, tablet, tablet chewable, tablet disintegrating, tablet extended release. Other dosage forms:
- intravenous solution
- oral granule
Serious side effects of Paracetamol
Along with its needed effects, acetaminophen (the active ingredient contained in Paracetamol) 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 rash, hives, 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, oral powder for reconstitution, oral suspension, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release, rectal suppository.
General
In general, acetaminophen (the active ingredient contained in Paracetamol) 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 reports: Anaphylaxis, 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, hypotension, tachycardia, chest pain[Ref]
Metabolic
Common (1% to 10%): Hypokalemia, hyperglycemia[Ref]
Nervous system
Common (1% to 10%): Headache, dizziness
Frequency not reported: Dystonia
Musculoskeletal
Common (1% to 10%): Muscle spasms, trismus
Psychiatric
Common (1% to 10%): Insomnia, anxiety
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
Frequently asked questions
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More about Paracetamol (acetaminophen)
- Check interactions
- Compare alternatives
- Reviews (13)
- Latest FDA alerts (16)
- Dosage information
- Patient tips
- During pregnancy
- Support group
- Drug class: miscellaneous analgesics
- Breastfeeding
Patient resources
- Paracetamol drug information
Other brands
Tylenol, Tylenol Arthritis Pain, Ofirmev, Mapap, ... +34 more
Professional resources
- Acetaminophen monograph
- Acetaminophen Injection (FDA)
Other brands
Tylenol Arthritis Pain, Ofirmev, Children's Tylenol, 7T Gummy ES Chewable Tablets
Related treatment guides
- Muscle Pain
- Fever
- Pain
- Sciatica
References
1. "Multum Information Services, Inc. Expert Review Panel"
2. Zimmerman HJ, Maddrey WC (1995) "Acetaminophen (paracetamol) hepatotoxicity with regular intake of alcohol: analysis of instances of therapeutic misadventure." Hepatology, 22, p.767-73
3. Gursoy M, Haznedaroglu IC, Celik I, Sayinalp N, Ozcebe OI, Dundar SV (1996) "Agranulocytosis, plasmacytosis, and thrombocytosis followed by a leukemoid reaction due to acute acetaminophen toxicity." Ann Pharmacother, 30, p.762-5
4. Kurtovic J, Riordan SM (2003) "Paracetamol-induced hepatotoxicity at recommended dosage." J Intern Med, 253, p.240-3
5. Vitols S (2003) "Paracetamol hepatotoxicity at therapeutic doses." J Intern Med, 253, p.95-8
6. Kaysen GA, Pond SM, Roper MH, Menke DJ, Marrama MA (1985) "Combined hepatic and renal injury in alcoholics during therapeutic use of acetaminophen." Arch Intern Med, 145, p.2019-23
7. O'Dell JR, Zetterman RK, Burnett DA (1986) "Centrilobular hepatic fibrosis following acetaminophen-induced hepatic necrosis in an alcoholic." JAMA, 255, p.2636-7
8. Seeff LB, Cuccherini BA, Zimmerman HJ, Adler E, Benjamin SB (1986) "Acetaminophen hepatotoxicity in alcoholics." Ann Intern Med, 104, p.399-404
9. Minton NA, Henry JA, Frankel RJ (1988) "Fatal paracetamol poisoning in an epileptic." Hum Toxicol, 7, p.33-4
10. Keaton MR (1988) "Acute renal failure in an alcoholic during therapeutic acetaminophen ingestion." South Med J, 81, p.1163-6
11. Shriner K, Goetz MB (1992) "Severe hepatotoxicity in a patient receiving both acetaminophen and zidovudine." Am J Med, 93, p.94-6
12. Keays R, Harrison PM, Wendon JA, et al. (1991) "Intravenous acetylcysteine in paracetamol induced fulminant hepatic failure: a prospective controlled trial." BMJ, 303, p.1026-9
13. Rumore MM, Blaiklock RG (1992) "Influence of age-dependent pharmaco*kinetics and metabolism on acetaminophen hepatotoxicity." J Pharm Sci, 81, p.203-7
14. Mofenson HC, Caraccio TR, Nawaz H, Steckler G (1991) "Acetaminophen induced pancreatitis." Clin Toxicol, 29, p.223-30
15. Kumar S, Rex DK (1991) "Failure of physicians to recognize acetaminophen hepatotoxicity in chronic alcoholics." Arch Intern Med, 151, p.1189-91
16. Block R, Jankowski JA, Lacoux P, Pennington CR (1992) "Does hypothermia protect against the development of hepatitis in paracetamol overdose?" Anaesthesia, 47, p.789-91
17. Brotodihardjo AE, Batey RG, Farrell GC, Byth K (1992) "Hepatotoxicity from paracetamol self-poisoning in Western Sydney: a continuing challenge." Med J Aust, 157, p.382-5
18. Johnson GK, Tolman KG (1977) "Chronic liver disease and acetaminophen." Ann Intern Med, 87, p.302-4
19. McJunkin B, Barwick KW, Little WC, Winfield JB (1976) "Fatal massive hepatic necrosis following acetaminophen overdose." JAMA, 236, p.1874-5
20. Block R (1993) "Liver failure induced by paracetamol." BMJ, 306, p.457
21. Wong V, Daly M, Boon A, Heatley V (1993) "Paracetamol and acute biliary pain with cholestasis." Lancet, 342, p.869
22. Bray GP (1993) "Liver failure induced by paracetamol." BMJ, 306, p.157-8
23. Lee WM (1994) "Acute liver failure." Am J Med, 96, p.3-9
24. Bonkovsky HL, Kane RE, Jones DP, Galinsky RE, Banner B (1994) "Acute hepatic and renal toxicity from low doses of acetaminophen in the absence of alcohol abuse or malnutrition - evidence for increased susceptibility to drug toxicity due to cardiopulmonary and renal insufficiency." Hepatology, 19, p.1141-8
25. Cheung L, Potts RG, Meyer KC (1994) "Acetaminophen treatment nomogram." N Engl J Med, 330, p.1907-8
26. Hartleb M (1994) "Do thyroid hormones promote hepatotoxicity to acetaminophen?" Am J Gastroenterol, 89, p.1269-70
27. Smilkstein MJ, Douglas Dr, Daya MR (1994) "Acetaminophen poisoning and liver function." N Engl J Med, 331, p.1310-1
28. Whitcomb DC (1994) "Acetaminophen poisoning and liver function." N Engl J Med, 331, p.1311
29. Cheung L, Meyer KC (1994) "Acetaminophen poisoning and liver function." N Engl J Med, 331, p.1311-2
30. Whitcomb DC, Block GD (1994) "Association of acetaminopphen hepatotoxicity with fasting and ethanol use." JAMA, 272, p.1845-50
31. Bonkovsky HL (1995) "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA, 274, p.301
32. Nelson EB, Temple AR (1995) "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA, 274, p.301
33. Singer AJ, Carracio TR, Mofenson HC (1995) "The temporal profile of increased transaminase levels in patients with acetaminophen-induced liver dysfunction." Ann Emerg Med, 26, p.49-53
34. Lee WM (1995) "Medical progress: drug-induced hepatotoxicity." N Engl J Med, 333, p.1118-27
35. Settipane RA, Stevenson DD (1989) "Cross sensitivity with acetaminophen in aspirin-sensitive subjects with asthma." J Allergy Clin Immunol, 84, p.26-33
36. Van Diem L, Grilliat JP (1990) "Anaphylactic shock induced by paracetamol." Eur J Clin Pharmacol, 38, p.389-90
37. Leung R, Plomley R, Czarny D (1992) "Paracetamol anaphylaxis." Clin Exp Allergy, 22, p.831-3
38. Doan T, Greenberger PA (1993) "Nearly fatal episodes of hypotension, flushing, and dyspnea in a 47- year-old woman." Ann Allergy, 70, p.439-44
39. Kalyoncu AF (1994) "Acetaminophen hypersensitivity and other analgesics." Ann Allergy, 72, p.285
40. Doan T (1994) "Acetaminophen hypersensitivity and other analgesics - response." Ann Allergy, 72, p.285
41. Kawada A, Hiruma M, Noguchi H, Ishibashi A (1996) "Fixed drug eruption induced by acetaminophen in a 12-year-old girl." Int J Dermatol, 35, p.148-9
42. Halevi A, BenAmitai D, Garty BZ (2000) "Toxic epidermal necrolysis associated with acetaminophen ingestion." Ann Pharmacother, 34, p.32-4
43. Shoenfeld Y, Shaklai M, Livni E, Pinkhas J (1980) "Thrombocytopenia from acetaminophen." N Engl J Med, 303, p.47
44. Bougie DW, Benito AI, Sanchez-Abarca LI, Torres R, Birenbaum J, Aster RH (2007) "Acute thrombocytopenia caused by sensitivity to the glucuronide conjugate of acetaminophen." Blood, 109, p.3608-9
45. Thomas RH, Munro DD (1986) "Fixed drug eruption due to paracetamol." Br J Dermatol, 115, p.357-9
46. Guccione JL, Zemtsov A, Cobos E, Neldner KH (1993) "Acquired purpura fulminans induced by alcohol and acetaminophen - successful treatment with heparin and vitamin-k." Arch Dermatol, 129, p.1267-9
47. Filipe PL, Freitas JP, Decastro JC, Silva R (1995) "Drug eruption induced by acetaminophen in infectious mononucleosis." Int J Dermatol, 34, p.220-1
48. Kondo K, Inoue Y, Hamada H, Yokoyama A, Kohno N, Hiwada K (1993) "Acetaminophen-induced eosinophilic pneumonia." Chest, 104, p.291-2
49. Brown G (1996) "Acetaminophen-induced hypotension." Heart Lung, 25, p.137-40
50. Koulouris Z, Tierney MG, Jones G (1999) "Metabolic acidosis and coma following a severe acetaminophen overdose." Ann Pharmacother, 33, p.1191-4
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circ*mstances.
Some side effects may not be reported. You may report them to the FDA.
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