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Nalocet Side Effects

Generic name: acetaminophen / oxycodone

Medically reviewed by Drugs.com. Last updated on Aug 23, 2022.

Note: This document contains side effect information about acetaminophen / oxycodone. Some dosage forms listed on this page may not apply to the brand name Nalocet.

Applies to acetaminophen / oxycodone: oral solution, oral tablet.

Warning

Oral route (Tablet; Tablet, Extended Release)

Addiction, Abuse, and MisuseOxycodone/acetaminophen exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing oxycodone/acetaminophen, and monitor all patients regularly for the development of these behaviors or conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of oxycodone/acetaminophen. Monitor for respiratory depression, especially during initiation of oxycodone/acetaminophen or following a dose increase.Instruct patients to swallow oxycodone/acetaminophen ER tablets whole; crushing, chewing, or dissolving oxycodone/acetaminophen ER can cause rapid release and absorption of a potentially fatal dose of oxycodone Accidental IngestionAccidental ingestion of even one dose of oxycodone/acetaminophen, especially by children, can result in a fatal overdose of oxycodone.Neonatal Opioid Withdrawal SyndromeProlonged use of oxycodone/acetaminophen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Cytochrome P450 3A4 InteractionThe concomitant use of Oxycodone/acetaminophen with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Oxycodone/acetaminophen and any CYP3A4 inhibitor or inducer.HepatotoxicityAcetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsReserve concomitant prescribing of oxycodone/acetaminophen and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Serious side effects of Nalocet

Along with its needed effects, acetaminophen / oxycodone 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 / oxycodone:

More common

Rare

  • Cough
  • fever with or without chills
  • general feeling of tiredness or weakness
  • hoarseness
  • lower back or side pain
  • painful or difficult urination
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • unusual bleeding or bruising

Incidence not known

  • Back, leg, or stomach pains
  • bleeding gums
  • bloating
  • blood in the urine or stools
  • blue lips and fingernails
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain, discomfort, or tightness
  • cloudy urine
  • clumsiness
  • confusion
  • constipation
  • coughing that sometimes produces a pink frothy sputum
  • darkening of the skin
  • decreased awareness or responsiveness
  • decreased frequency or amount of urine
  • diarrhea
  • difficult, fast, noisy breathing
  • difficulty in passing urine (dribbling)
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • dry mouth
  • extremely shallow or slow breathing
  • fainting
  • fast or deep breathing
  • fast, slow, irregular, pounding, or racing heartbeat
  • feeling of warmth
  • general body swelling
  • hives or welts
  • increased sweating
  • increased thirst
  • indigestion
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • lightheadedness
  • mental depression
  • muscle aches, tremors, or weakness
  • nervousness
  • nosebleeds
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid, deep or shallow breathing
  • redness of the face, neck, arms, and occasionally, upper chest
  • restlessness
  • seizures
  • severe constipation
  • severe sleepiness
  • severe vomiting
  • skin blisters
  • sleepiness
  • stomach cramps
  • sunken eyes
  • sweating
  • swelling of the face, fingers, lower legs, or ankles
  • thirst
  • tiredness
  • trouble breathing
  • vomiting
  • weakness or heaviness of the legs
  • weight gain

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / oxycodone:

Symptoms of overdose

  • Bluish lips or skin
  • change in consciousness
  • cold, clammy skin
  • extreme sleepiness
  • general feeling of discomfort or illness
  • loss of consciousness
  • low blood pressure or pulse
  • slow breathing
  • unconsciousness

Other side effects of Nalocet

Some side effects of acetaminophen / oxycodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Relaxed and calm feeling

Incidence not known

  • Agitation
  • bad, unusual or unpleasant (after) taste
  • belching
  • change in taste
  • cold sweats
  • constricted, pinpoint, or small pupils (black part of the eye)
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cool, pale skin
  • depression
  • difficulty with moving
  • disturbed color perception
  • double vision
  • excess air or gas in the stomach or bowels
  • false or unusual sense of well-being
  • flushed, dry skin
  • fruit-like breath odor
  • full feeling
  • general feeling of discomfort or illness
  • halos around lights
  • hearing loss
  • heartburn
  • increased hunger
  • increased urination
  • indigestion
  • joint pain
  • lack or loss of strength
  • muscle cramps, spasms, pain, or stiffness
  • night blindness
  • nightmares
  • overbright appearance of lights
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shakiness
  • slurred speech
  • swollen joints
  • trouble sleeping
  • tunnel vision
  • unexplained weight loss
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

For Healthcare Professionals

Applies to acetaminophen / oxycodone: oral capsule, oral solution, oral tablet, oral tablet extended release.

General

The most commonly reported adverse events have included lightheadedness, dizziness, drowsiness, sedation, nausea, and vomiting.[Ref]

Respiratory

Common (1% to 10%): Cough

Frequency not reported: Apnea, respiratory arrest, respiratory depression, hiccups

Postmarketing reports: Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, hypoventilation, laryngeal edema[Ref]

Hepatic

Oxycodone-acetaminophen:

Postmarketing reports: Transient elevations of hepatic enzymes, increased bilirubin, hepatic failure, jaundice, hepatotoxicity, hepatic disorder, hepatitis

Acetaminophen:

Frequency not reported: Hepatic necrosis[Ref]

At high doses, the most serious acetaminophen related adverse event is a dose-dependent, potentially fatal hepatic necrosis.[Ref]

Hypersensitivity

Frequency not reported: Skin eruptions, urticaria, erythematous skin reactions

Postmarketing reports: Anaphylaxis, allergic reaction, angioedema[Ref]

Dermatologic

Common (1% to 10%): Rash, blister, excoriation, pruritus, erythema

Frequency not reported: Dermatitis, ecchymosis, hyperhidrosis

Postmarketing reports: Urticaria, flushing, increased sweating[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 13%)

Common (1% to 10%): Headache, somnolence

Frequency not reported: Lightheadedness, dizziness, drowsiness, sedation, migraine, myoclonus, paresthesia, tremor

Postmarketing reports: Stupor, cerebral edema, coma, subdural or intracranial hemorrhage, seizures

Opioids:

Postmarketing reports: Serotonin syndrome[Ref]

Psychiatric

Frequency not reported: Euphoria, dysphoria, insomnia, altered mood, sleep disorder, withdrawal syndrome

Postmarketing reports: Agitation, confusion, anxiety, mental impairment, drug dependence, drug abuse, depression, nervousness, hallucination, suicide[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 31%)

Common (1% to 10%): Vomiting, constipation, dry mouth, dyspepsia, diarrhea

Frequency not reported: Esophageal spasm, oropharyngeal pain, throat irritation

Postmarketing reports: Abdominal pain, abdominal distention, flatulence, gastrointestinal disorder, pancreatitis, intestinal obstruction, ileus, thirst[Ref]

Hematologic

Oxycodone-acetaminophen:

Frequency not reported: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia

Acetaminophen:

Rare (0.01% to 0.1%): Agranulocytosis[Ref]

Renal

Postmarketing reports: Renal insufficiency and failure[Ref]

Cardiovascular

Common (1% to 10%): Edema

Frequency not reported: Hypotension, chest discomfort

Postmarketing reports: Tachycardia, dysrhythmias, orthostatic hypotension, bradycardia, palpitations, hypertension[Ref]

Metabolic

Frequency not reported: Decreased appetite

Postmarketing reports: Hypoglycemia, hyperglycemia, acidosis, alkalosis, hyperkalemia, dehydration

Musculoskeletal

Postmarketing reports: Rhabdomyolysis, myalgia

Ocular

Postmarketing reports: Miosis, visual disturbances, red eye

Genitourinary

Common (1% to 10%): Dysuria

Frequency not reported: Urinary retention, interstitial nephritis, proteinuria, decreased urine flow

Other

Postmarketing reports: Malaise, asthenia, fatigue, fever, hypothermia, accidental overdose, non-accidental overdose, hearing loss, tinnitus[Ref]

Endocrine

Adrenal insufficiency and androgen deficiency have been reported with opioid use, most often with chronic use.

Opioids:

Postmarketing reports: Adrenal insufficiency, androgen deficiency

References

1. Leow KP, Smith MT, Watt JA, Williams BE, Cramond T "Comparative oxycodone pharmacokinetics in humans after intravenous, oral, and rectal administration." Ther Drug Monit 14 (1992): 479-84

2. "Multum Information Services, Inc. Expert Review Panel"

3. "Product Information. Percocet 5/325 (acetaminophen-oxycodone)." Endo Laboratories LLC (2017):

4. "Product Information. Xartemis XR (acetaminophen-oxycodone)." Mallinckrodt Medical Inc (2017):

5. "Product Information. Acetaminophen-Oxycodone Hydrochloride (acetaminophen-oxycodone)." Mallinckrodt Medical Inc (2017):

6. "Product Information. Percocet (acetaminophen-oxycodone)." DuPont Pharmaceuticals (2001):

7. Kondo K, Inoue Y, Hamada H, Yokoyama A, Kohno N, Hiwada K "Acetaminophen-induced eosinophilic pneumonia." Chest 104 (1993): 291-2

8. 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

9. O'Dell JR, Zetterman RK, Burnett DA "Centrilobular hepatic fibrosis following acetaminophen-induced hepatic necrosis in an alcoholic." JAMA 255 (1986): 2636-7

10. Seeff LB, Cuccherini BA, Zimmerman HJ, Adler E, Benjamin SB "Acetaminophen hepatotoxicity in alcoholics." Ann Intern Med 104 (1986): 399-404

11. Minton NA, Henry JA, Frankel RJ "Fatal paracetamol poisoning in an epileptic." Hum Toxicol 7 (1988): 33-4

12. Keaton MR "Acute renal failure in an alcoholic during therapeutic acetaminophen ingestion." South Med J 81 (1988): 1163-6

13. Shriner K, Goetz MB "Severe hepatotoxicity in a patient receiving both acetaminophen and zidovudine." Am J Med 93 (1992): 94-6

14. 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

15. Rumore MM, Blaiklock RG "Influence of age-dependent pharmacokinetics and metabolism on acetaminophen hepatotoxicity." J Pharm Sci 81 (1992): 203-7

16. Mofenson HC, Caraccio TR, Nawaz H, Steckler G "Acetaminophen induced pancreatitis." Clin Toxicol 29 (1991): 223-30

17. Kumar S, Rex DK "Failure of physicians to recognize acetaminophen hepatotoxicity in chronic alcoholics." Arch Intern Med 151 (1991): 1189-91

18. Block R, Jankowski JA, Lacoux P, Pennington CR "Does hypothermia protect against the development of hepatitis in paracetamol overdose?" Anaesthesia 47 (1992): 789-91

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. Johnson GK, Tolman KG "Chronic liver disease and acetaminophen." Ann Intern Med 87 (1977): 302-4

21. McJunkin B, Barwick KW, Little WC, Winfield JB "Fatal massive hepatic necrosis following acetaminophen overdose." JAMA 236 (1976): 1874-5

22. Block R "Liver failure induced by paracetamol." BMJ 306 (1993): 457

23. Wong V, Daly M, Boon A, Heatley V "Paracetamol and acute biliary pain with cholestasis." Lancet 342 (1993): 869

24. Bray GP "Liver failure induced by paracetamol." BMJ 306 (1993): 157-8

25. Lee WM "Acute liver failure." Am J Med 96 (1994): 3-9

26. 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

27. Cheung L, Potts RG, Meyer KC "Acetaminophen treatment nomogram." N Engl J Med 330 (1994): 1907-8

28. Hartleb M "Do thyroid hormones promote hepatotoxicity to acetaminophen?" Am J Gastroenterol 89 (1994): 1269-70

29. Smilkstein MJ, Douglas Dr, Daya MR "Acetaminophen poisoning and liver function." N Engl J Med 331 (1994): 1310-1

30. Whitcomb DC "Acetaminophen poisoning and liver function." N Engl J Med 331 (1994): 1311

31. Cheung L, Meyer KC "Acetaminophen poisoning and liver function." N Engl J Med 331 (1994): 1311-2

32. Whitcomb DC, Block GD "Association of acetaminopphen hepatotoxicity with fasting and ethanol use." JAMA 272 (1994): 1845-50

33. Bonkovsky HL "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA 274 (1995): 301

34. Nelson EB, Temple AR "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA 274 (1995): 301

35. 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

36. Zimmerman HJ, Maddrey WC "Acetaminophen (paracetamol) hepatotoxicity with regular intake of alcohol: analysis of instances of therapeutic misadventure." Hepatology 22 (1995): 767-73

37. Lee WM "Medical progress: drug-induced hepatotoxicity." N Engl J Med 333 (1995): 1118-27

38. Bolesta S, Haber SL "Hepatotoxicity associated with chronic acetaminophen administration in patients without risk factors." Ann Pharmacother 36 (2002): 331-3

39. Settipane RA, Stevenson DD "Cross sensitivity with acetaminophen in aspirin-sensitive subjects with asthma." J Allergy Clin Immunol 84 (1989): 26-33

40. Van Diem L, Grilliat JP "Anaphylactic shock induced by paracetamol." Eur J Clin Pharmacol 38 (1990): 389-90

41. Leung R, Plomley R, Czarny D "Paracetamol anaphylaxis." Clin Exp Allergy 22 (1992): 831-3

42. Doan T, Greenberger PA "Nearly fatal episodes of hypotension, flushing, and dyspnea in a 47- year-old woman." Ann Allergy 70 (1993): 439-44

43. Kalyoncu AF "Acetaminophen hypersensitivity and other analgesics." Ann Allergy 72 (1994): 285

44. Doan T "Acetaminophen hypersensitivity and other analgesics - response." Ann Allergy 72 (1994): 285

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. Leow KP, Smith MT, Williams B, Cramond T "Single-dose and steady-state pharmacokinetics and pharmacodynamics of oxycodone in patients with cancer." Clin Pharmacol Ther 52 (1992): 487-95

49. Glare P, Walsh D "Dose-ranging study of oxycodone for advanced cancer pain (meeting abstract)." Proc Annu Meet Am Soc Clin Oncol 10 (1991): a1201

50. Glare PA, Walsh TD "Dose-ranging study of oxycodone for chronic pain in advanced cancer." J Clin Oncol 11 (1993): 973-8

51. Sunshine A, Olson NZ, Zighelboim I, Decastro A "Ketoprofen, acetaminophen plus oxycodone, and acetaminophen in the relief of postoperative pain." Clin Pharmacol Ther 54 (1993): 546-55

52. Fishbain DA, Goldberg M, Rosomoff RS, Rosomoff H "Atypical withdrawal syndrome (organic delusional syndrome) secondary to oxycodone detoxification ." J Clin Psychopharmacol 8 (1988): 441-2

53. Shoenfeld Y, Shaklai M, Livni E, Pinkhas J "Thrombocytopenia from acetaminophen." N Engl J Med 303 (1980): 47

54. 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

55. Kleinman JG, Breitenfield RV, Roth DA "Transient cholestatic hepatitis in a neonate associated with carbamazepine exposure during pregnancy and breast-feeding." Clin Nephrol 14 (1980): 201-5

56. Segasothy M, Suleiman AB, Puvaneswary M, Rohana A "Paracetamol: a cause for analgesic nephropathy and end-stage renal disease." Nephron 50 (1988): 50-4

57. Duchene A, Chadenas D, Marneffe-Lebrequier H "Insuffisance renale aigue isolee apres intoxication volontaire par le paracetamol." Presse Med 20 (1991): 1684-5

58. Curry RW, Robinson JD, Sughrue MJ "Acute renal failure after acetaminophen ingestion." JAMA 247 (1982): 1012-4

59. Goldberg M "Analgesic nephropathy in 1981: which drug is responsible?" JAMA 247 (1982): 64-5

60. Boyer TD, Rouff SL "Acetaminophen-induced hepatic necrosis and renal failure." JAMA 218 (1971): 440-1

61. Vanchieri C "Australian study links certain analgesics to renal cancers." J Natl Cancer Inst 85 (1993): 262-3

62. McCredie M, Stewart JH, Day NE "Different roles for phenacetin and paracetamol in cancer of the kidney and renal pelvis." Int J Cancer 53 (1993): 245-9

63. Drenth JP, Frenken LA, Wuis EW, Van der Meer JW "Acute renal failure associated with paracetamol ingestion in an alcoholic patient." Nephron 67 (1994): 483-5

64. Perneger TV, Whelton PK, Klag MJ "Risk of kidney failure associated with the use of acetaminophen, aspirin, and nonsteroidal antiinflammatory drugs." N Engl J Med 331 (1994): 1675-79

65. Brown G "Acetaminophen-induced hypotension." Heart Lung 25 (1996): 137-40

66. Gardos G "Dyskinesia after discountinuation of compound analgesic containing oxycodone ." Lancet 1 (1977): 759-60

Further information

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.

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