Tylenol Extra Strength Side Effects
Generic name: acetaminophen
Medically reviewed by Drugs.com. Last updated on May 14, 2023.
Note: This document contains side effect information about acetaminophen. Some dosage forms listed on this page may not apply to the brand name Tylenol Extra Strength.
Applies to acetaminophen: capsule, capsule liquid filled, elixir, liquid, powder, solution, suppository, suspension, tablet, tablet chewable, tablet disintegrating, tablet extended release. Other dosage forms:
Serious side effects
Along with its needed effects, acetaminophen (the active ingredient contained in Tylenol Extra Strength) 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:
- 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
- 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.
In general, acetaminophen (the active ingredient contained in Tylenol Extra Strength) 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]
Common (1% to 10%): Increased aspartate aminotransferase
Rare (less than 0.1%): Increased hepatic transaminases
Frequency not reported: Liver failure[Ref]
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]
Postmarketing reports: Anaphylaxis, hypersensitivity reactions[Ref]
Common (1% to 10%): Anemia, postoperative hemorrhage
Very rare (less than 0.01%): Thrombocytopenia, leucopenia, neutropenia[Ref]
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]
Common (1% to 10%): Dyspnea, abnormal breath sounds, pulmonary edema, hypoxia, pleural effusion, stridor, wheezing, coughing[Ref]
Common (1% to 10%): Peripheral edema, hypertension, hypotension, tachycardia, chest pain[Ref]
Common (1% to 10%): Hypokalemia, hyperglycemia[Ref]
Common (1% to 10%): Headache, dizziness
Frequency not reported: Dystonia
Common (1% to 10%): Muscle spasms, trismus
Common (1% to 10%): Insomnia, anxiety
Common (1% to 10%): Oliguria
Common (1% to 10%): Infusion site pain, injection site reactions
Common (1% to 10%): Periorbital edema
Common (1% to 10%): Pyrexia, fatigue
Rare (0.01% to 0.1%): Malaise
Frequently asked questions
- What's the best sore throat medicine to use?
- What medications cause liver enzymes to be elevated?
- Which painkiller should you use?
- What is paracetamol / panadol called in the US?
- Acetaminophen vs Ibuprofen: Which is better?
- How long does Percocet stay in your system?
- Can you take tramadol with acetaminophen, ibuprofen, or aspirin?
- Advil (ibuprofen) & Tylenol (acetaminophen) together, is it safe?
- Is it safe to take acetaminophen every day?
- How long does it take for Tylenol to start working?
- Is acetaminophen the same as Tylenol?
- Is Tylenol (acetaminophen) a blood thinner?
- Is acetaminophen (Tylenol) an NSAID Drug?
- Can you take paracetamol (acetaminophen) with antibiotics?
- Is Tylenol (acetaminophen) an anti-inflammatory drug?
More about Tylenol Extra Strength (acetaminophen)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (5)
- Drug images
- Latest FDA alerts (19)
- Dosage information
- During pregnancy
- Drug class: miscellaneous analgesics
Paracetamol, Ofirmev, Mapap, Acephen, ... +28 more
Related treatment guides
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. 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
4. Kurtovic J, Riordan SM "Paracetamol-induced hepatotoxicity at recommended dosage." J Intern Med 253 (2003): 240-3
5. Vitols S "Paracetamol hepatotoxicity at therapeutic doses." J Intern Med 253 (2003): 95-8
6. 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
7. O'Dell JR, Zetterman RK, Burnett DA "Centrilobular hepatic fibrosis following acetaminophen-induced hepatic necrosis in an alcoholic." JAMA 255 (1986): 2636-7
8. Seeff LB, Cuccherini BA, Zimmerman HJ, Adler E, Benjamin SB "Acetaminophen hepatotoxicity in alcoholics." Ann Intern Med 104 (1986): 399-404
9. Minton NA, Henry JA, Frankel RJ "Fatal paracetamol poisoning in an epileptic." Hum Toxicol 7 (1988): 33-4
10. Keaton MR "Acute renal failure in an alcoholic during therapeutic acetaminophen ingestion." South Med J 81 (1988): 1163-6
11. Shriner K, Goetz MB "Severe hepatotoxicity in a patient receiving both acetaminophen and zidovudine." Am J Med 93 (1992): 94-6
12. 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
13. Rumore MM, Blaiklock RG "Influence of age-dependent pharmacokinetics and metabolism on acetaminophen hepatotoxicity." J Pharm Sci 81 (1992): 203-7
14. Mofenson HC, Caraccio TR, Nawaz H, Steckler G "Acetaminophen induced pancreatitis." Clin Toxicol 29 (1991): 223-30
15. Kumar S, Rex DK "Failure of physicians to recognize acetaminophen hepatotoxicity in chronic alcoholics." Arch Intern Med 151 (1991): 1189-91
16. Block R, Jankowski JA, Lacoux P, Pennington CR "Does hypothermia protect against the development of hepatitis in paracetamol overdose?" Anaesthesia 47 (1992): 789-91
17. 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
18. Johnson GK, Tolman KG "Chronic liver disease and acetaminophen." Ann Intern Med 87 (1977): 302-4
19. McJunkin B, Barwick KW, Little WC, Winfield JB "Fatal massive hepatic necrosis following acetaminophen overdose." JAMA 236 (1976): 1874-5
20. Block R "Liver failure induced by paracetamol." BMJ 306 (1993): 457
21. Wong V, Daly M, Boon A, Heatley V "Paracetamol and acute biliary pain with cholestasis." Lancet 342 (1993): 869
22. Bray GP "Liver failure induced by paracetamol." BMJ 306 (1993): 157-8
23. Lee WM "Acute liver failure." Am J Med 96 (1994): 3-9
24. Bonkovsky HL, Kane RE, Jones DP, Galinsky RE, Banner B "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 (1994): 1141-8
25. Cheung L, Potts RG, Meyer KC "Acetaminophen treatment nomogram." N Engl J Med 330 (1994): 1907-8
26. Hartleb M "Do thyroid hormones promote hepatotoxicity to acetaminophen?" Am J Gastroenterol 89 (1994): 1269-70
27. Smilkstein MJ, Douglas Dr, Daya MR "Acetaminophen poisoning and liver function." N Engl J Med 331 (1994): 1310-1
28. Whitcomb DC "Acetaminophen poisoning and liver function." N Engl J Med 331 (1994): 1311
29. Cheung L, Meyer KC "Acetaminophen poisoning and liver function." N Engl J Med 331 (1994): 1311-2
30. Whitcomb DC, Block GD "Association of acetaminopphen hepatotoxicity with fasting and ethanol use." JAMA 272 (1994): 1845-50
31. Bonkovsky HL "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA 274 (1995): 301
32. Nelson EB, Temple AR "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA 274 (1995): 301
33. 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
34. Lee WM "Medical progress: drug-induced hepatotoxicity." N Engl J Med 333 (1995): 1118-27
35. Settipane RA, Stevenson DD "Cross sensitivity with acetaminophen in aspirin-sensitive subjects with asthma." J Allergy Clin Immunol 84 (1989): 26-33
36. Van Diem L, Grilliat JP "Anaphylactic shock induced by paracetamol." Eur J Clin Pharmacol 38 (1990): 389-90
37. Leung R, Plomley R, Czarny D "Paracetamol anaphylaxis." Clin Exp Allergy 22 (1992): 831-3
38. Doan T, Greenberger PA "Nearly fatal episodes of hypotension, flushing, and dyspnea in a 47- year-old woman." Ann Allergy 70 (1993): 439-44
39. Kalyoncu AF "Acetaminophen hypersensitivity and other analgesics." Ann Allergy 72 (1994): 285
40. Doan T "Acetaminophen hypersensitivity and other analgesics - response." Ann Allergy 72 (1994): 285
41. Kawada A, Hiruma M, Noguchi H, Ishibashi A "Fixed drug eruption induced by acetaminophen in a 12-year-old girl." Int J Dermatol 35 (1996): 148-9
42. Halevi A, BenAmitai D, Garty BZ "Toxic epidermal necrolysis associated with acetaminophen ingestion." Ann Pharmacother 34 (2000): 32-4
43. Shoenfeld Y, Shaklai M, Livni E, Pinkhas J "Thrombocytopenia from acetaminophen." N Engl J Med 303 (1980): 47
44. Bougie DW, Benito AI, Sanchez-Abarca LI, Torres R, Birenbaum J, Aster RH "Acute thrombocytopenia caused by sensitivity to the glucuronide conjugate of acetaminophen." Blood 109 (2007): 3608-9
45. Thomas RH, Munro DD "Fixed drug eruption due to paracetamol." Br J Dermatol 115 (1986): 357-9
46. Guccione JL, Zemtsov A, Cobos E, Neldner KH "Acquired purpura fulminans induced by alcohol and acetaminophen - successful treatment with heparin and vitamin-k." Arch Dermatol 129 (1993): 1267-9
47. Filipe PL, Freitas JP, Decastro JC, Silva R "Drug eruption induced by acetaminophen in infectious mononucleosis." Int J Dermatol 34 (1995): 220-1
48. Kondo K, Inoue Y, Hamada H, Yokoyama A, Kohno N, Hiwada K "Acetaminophen-induced eosinophilic pneumonia." Chest 104 (1993): 291-2
49. Brown G "Acetaminophen-induced hypotension." Heart Lung 25 (1996): 137-40
50. Koulouris Z, Tierney MG, Jones G "Metabolic acidosis and coma following a severe acetaminophen overdose." Ann Pharmacother 33 (1999): 1191-4
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.