Acetaminophen / pentazocine Side Effects
For the Consumer
Applies to acetaminophen / pentazocine: oral tablet
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Very bad dizziness or passing out.
- Trouble breathing, slow breathing, or shallow breathing.
- Feeling confused.
- Very upset stomach or throwing up.
- Very hard stools (constipation).
- Feeling very tired or weak.
- A fast heartbeat.
- Fever or chills.
- Sore throat.
- Hallucinations (seeing or hearing things that are not there).
- Mood changes.
- Very bad headache.
- Not able to sleep.
- Trouble passing urine.
- Change in eyesight.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this drug with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
- Taking an opioid drug like this drug may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Hard stools (constipation).
- Feeling sleepy.
- Upset stomach.
- Sweating a lot.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
In general, acetaminophen is well tolerated when administered in therapeutic doses.[Ref]
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 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 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]
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]
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 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]
A 19-year-old female developed hepatotoxicity, reactive plasmacytosis, and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.[Ref]
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 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]
Acetaminophen-related acute tubular necrosis usually occurred in conjunction with liver failure, but has been observed as an isolated finding in rare cases.[Ref]
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 side effects associated with pentazocine have included sweating, flushing, and chills.[Ref]
Ocular side effects associated with pentazocine have included miosis, visual blurring, and focusing difficulty.[Ref]
1. "Product Information. Talacen (acetaminophen-pentazocine)." Sanofi-Synthelabo Inc, New York, NY.
2. Brown G "Acetaminophen-induced hypotension." Heart Lung 25 (1996): 137-40
3. Filipe PL, Freitas JP, Decastro JC, Silva R "Drug eruption induced by acetaminophen in infectious mononucleosis." Int J Dermatol 34 (1995): 220-1
4. 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
5. Lee WM "Medical progress: drug-induced hepatotoxicity." N Engl J Med 333 (1995): 1118-27
6. Whitcomb DC, Block GD "Association of acetaminopphen hepatotoxicity with fasting and ethanol use." JAMA 272 (1994): 1845-50
7. Mofenson HC, Caraccio TR, Nawaz H, Steckler G "Acetaminophen induced pancreatitis." Clin Toxicol 29 (1991): 223-30
8. Cheung L, Meyer KC "Acetaminophen poisoning and liver function." N Engl J Med 331 (1994): 1311-2
9. Minton NA, Henry JA, Frankel RJ "Fatal paracetamol poisoning in an epileptic." Hum Toxicol 7 (1988): 33-4
10. McJunkin B, Barwick KW, Little WC, Winfield JB "Fatal massive hepatic necrosis following acetaminophen overdose." JAMA 236 (1976): 1874-5
11. Zimmerman HJ, Maddrey WC "Acetaminophen (paracetamol) hepatotoxicity with regular intake of alcohol: analysis of instances of therapeutic misadventure." Hepatology 22 (1995): 767-73
12. Block R, Jankowski JA, Lacoux P, Pennington CR "Does hypothermia protect against the development of hepatitis in paracetamol overdose?" Anaesthesia 47 (1992): 789-91
13. Kumar S, Rex DK "Failure of physicians to recognize acetaminophen hepatotoxicity in chronic alcoholics." Arch Intern Med 151 (1991): 1189-91
14. Bonkovsky HL "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA 274 (1995): 301
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. Hartleb M "Do thyroid hormones promote hepatotoxicity to acetaminophen?" Am J Gastroenterol 89 (1994): 1269-70
17. O'Dell JR, Zetterman RK, Burnett DA "Centrilobular hepatic fibrosis following acetaminophen-induced hepatic necrosis in an alcoholic." JAMA 255 (1986): 2636-7
18. 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
19. 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
20. Block R "Liver failure induced by paracetamol." BMJ 306 (1993): 457
21. 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
22. Cheung L, Potts RG, Meyer KC "Acetaminophen treatment nomogram." N Engl J Med 330 (1994): 1907-8
23. Johnson GK, Tolman KG "Chronic liver disease and acetaminophen." Ann Intern Med 87 (1977): 302-4
24. Bolesta S, Haber SL "Hepatotoxicity associated with chronic acetaminophen administration in patients without risk factors." Ann Pharmacother 36 (2002): 331-3
25. Nelson EB, Temple AR "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA 274 (1995): 301
26. Seeff LB, Cuccherini BA, Zimmerman HJ, Adler E, Benjamin SB "Acetaminophen hepatotoxicity in alcoholics." Ann Intern Med 104 (1986): 399-404
27. 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
28. Smilkstein MJ, Douglas Dr, Daya MR "Acetaminophen poisoning and liver function." N Engl J Med 331 (1994): 1310-1
29. Medrano J, Padierna JA "Disappearance of psychosis after buspirone treatment." Am J Psychiatry 153 (1996): 293
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 127(Pt 4) (2003): 311-5
31. Shoenfeld Y, Shaklai M, Livni E, Pinkhas J "Thrombocytopenia from acetaminophen." N Engl J Med 303 (1980): 47
32. Van Diem L, Grilliat JP "Anaphylactic shock induced by paracetamol." Eur J Clin Pharmacol 38 (1990): 389-90
33. Doan T "Acetaminophen hypersensitivity and other analgesics - response." Ann Allergy 72 (1994): 285
34. Shriner K, Goetz MB "Severe hepatotoxicity in a patient receiving both acetaminophen and zidovudine." Am J Med 93 (1992): 94-6
35. Kalyoncu AF "Acetaminophen hypersensitivity and other analgesics." Ann Allergy 72 (1994): 285
36. Settipane RA, Stevenson DD "Cross sensitivity with acetaminophen in aspirin-sensitive subjects with asthma." J Allergy Clin Immunol 84 (1989): 26-33
37. Segasothy M, Suleiman AB, Puvaneswary M, Rohana A "Paracetamol: a cause for analgesic nephropathy and end-stage renal disease." Nephron 50 (1988): 50-4
38. 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
39. Goldberg M "Analgesic nephropathy in 1981: which drug is responsible?" JAMA 247 (1982): 64-5
40. 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
41. Duchene A, Chadenas D, Marneffe-Lebrequier H "Insuffisance renale aigue isolee apres intoxication volontaire par le paracetamol." Presse Med 20 (1991): 1684-5
42. Boyer TD, Rouff SL "Acetaminophen-induced hepatic necrosis and renal failure." JAMA 218 (1971): 440-1
43. Curry RW, Robinson JD, Sughrue MJ "Acute renal failure after acetaminophen ingestion." JAMA 247 (1982): 1012-4
44. Kondo K, Inoue Y, Hamada H, Yokoyama A, Kohno N, Hiwada K "Acetaminophen-induced eosinophilic pneumonia." Chest 104 (1993): 291-2
Some side effects of acetaminophen / pentazocine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
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