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Acetaminophen / pentazocine Side Effects

Applies to acetaminophen/pentazocine: oral tablet.

Warning

Oral route (Tablet)

Talacen® contains pentazocine hydrochloride and acetaminophen. Acetaminophen has been associated with acute liver failure, with some cases resulting in liver transplant and death. Most cases of liver injury were associated with acetaminophen use at doses exceeding 4000 mg/day, and often involved more than 1 acetaminophen-containing product

Serious side effects

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

Rare

Incidence not known

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

Symptoms of overdose

Other side effects

Some side effects of acetaminophen / pentazocine 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:

Rare

Incidence not known

For Healthcare Professionals

Applies to acetaminophen / pentazocine: oral tablet.

General

In general, acetaminophen is well tolerated when administered in therapeutic doses.[Ref]

Cardiovascular

Two cases of hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.[Ref]

Cardiovascular side effects associated with acetaminophen have included at least two cases of hypotension. Hypertension, hypotension, circulatory depression, and tachycardia have been reported with pentazocine.[Ref]

Nervous system

Nervous system side effects associated with pentazocine have included grand mal convulsions, increased intracranial pressure, dizziness, lightheadedness, hallucinations, sedation, headache, confusion, disorientation, weakness, insomnia, syncope, tremor, excitement, tinnitus, and paresthesia. Acute central nervous system side effects associated with pentazocine have also included hallucinations (usually visual), confusion, and disorientation.[Ref]

Dermatologic

Dermatologic side effects associated with acetaminophen have included general erythematous skin rashes (rare). Cases of bullous erythema and purpura fulminans associated with acetaminophen have been reported. Acetaminophen has been associated with a risk of rare but potentially fatal serious skin reactions know as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). Serious skin reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported with pentazocine.[Ref]

Gastrointestinal

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.[Ref]

Gastrointestinal side effects associated with acetaminophen were rare except in alcoholics and after overdose. Nausea, vomiting, and diarrhea have been reported with ordinary doses of acetaminophen. Acetaminophen may precipitate acute biliary pain and cholestasis. Cases of acute pancreatitis have been reported rarely. Nausea, vomiting, constipation, abdominal distress, anorexia, dry mouth, biliary tract spasm, and diarrhea have been reported with pentazocine.[Ref]

Hepatic

Hepatotoxicity may be increased by thyroid drugs, zidovudine, fasting, or alcohol use.

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. Hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

A 19-year-old female developed hepatotoxicity, reactive plasmacytosis, and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.[Ref]

Hepatic side effects associated with acetaminophen have included hepatic dysfunction which may occur after overdose. In this setting, severe and sometimes fatal dose-dependent hepatitis has been reported. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity. Hepatotoxicity, reactive plasmacytosis, and agranulocytosis followed by a leukemoid reaction have been reported after acute acetaminophen toxicity.[Ref]

Hematologic

A 19-year-old female developed hepatotoxicity, reactive plasmacytosis, and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.[Ref]

Hematologic side effects associated with acetaminophen have included rare cases of thrombocytopenia. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose. Hepatotoxicity, reactive plasmacytosis, and agranulocytosis followed by a leukemoid reaction have been reported after acute acetaminophen toxicity. Depression of white blood cells (especially granulocytes) with rare cases of agranulocytosis, which is usually reversible, and moderate transient eosinophilia have been reported with pentazocine.[Ref]

Hypersensitivity

Hypersensitivity side effects associated with acetaminophen have included rare reports of anaphylaxis and fixed drug eruptions. A few cases of acetaminophen hypersensitivity (as manifested by anaphylaxis, angioneurotic edema, skin rashes, thrombocytopenic purpura, and rarely hemolytic anemia and agranulocytosis) have been reported. Rash, urticaria, edema of the face, anaphylactic shock, dermatitis including pruritus, flushed skin including plethora, and in at least one case, an apparent anaphylactic reaction have been reported with pentazocine.[Ref]

Renal

Acetaminophen-related acute tubular necrosis usually occurred in conjunction with liver failure, but has been observed as an isolated finding in rare cases.[Ref]

Renal side effects associated with acetaminophen have been reported rarely and have included acute tubular necrosis and interstitial nephritis. Additional adverse renal effects were most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity. A possible increased risk of renal cell carcinoma has been associated with chronic acetaminophen use. A recent case-control study of patients with end-stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end-stage renal disease, particularly in patients taking more than two tablets per day.[Ref]

Respiratory

Respiratory side effects associated with acetaminophen have included a case of eosinophilic pneumonia. Respiratory depression has been reported with pentazocine.[Ref]

Psychiatric

Psychiatric side effects associated with pentazocine have included euphoria, depression, irritability, and disturbed dreams. Dependence and withdrawal symptoms have been reported with pentazocine.[Ref]

Other

Other side effects associated with pentazocine have included sweating, flushing, and chills.[Ref]

Genitourinary

Genitourinary side effects associated with pentazocine have included urinary retention and alterations in rate or strength of uterine contractions during labor.[Ref]

Ocular

Ocular side effects associated with pentazocine have included miosis, visual blurring, and focusing difficulty.[Ref]

References

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4. Filipe PL, Freitas JP, Decastro JC, Silva R. Drug eruption induced by acetaminophen in infectious mononucleosis. Int J Dermatol. 1995;34:220-1.

5. 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. 1985;145:2019-23.

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

8. Minton NA, Henry JA, Frankel RJ. Fatal paracetamol poisoning in an epileptic. Hum Toxicol. 1988;7:33-4.

9. Keays R, Harrison PM, Wendon JA, et al. Intravenous acetylcysteine in paracetamol induced fulminant hepatic failure: a prospective controlled trial. BMJ. 1991;303:1026-9.

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30. Bork S, Yokoyama N, Matsuo T, Claveria FG, Fujisaki K, Igarashi I. Clotrimazole, ketoconazole, and clodinafop-propargyl inhibit the in vitro growth of Babesia bigemina and Babesia bovis (Phylum Apicomplexa). Parasitology. 2003;127(Pt 4):311-5.

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

33. Van Diem L, Grilliat JP. Anaphylactic shock induced by paracetamol. Eur J Clin Pharmacol. 1990;38:389-90.

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

35. Kalyoncu AF. Acetaminophen hypersensitivity and other analgesics. Ann Allergy. 1994;72:285.

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

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

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

43. 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. 1994;331:1675-79.

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

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.