Talacen Side Effects

Generic name: acetaminophen / pentazocine

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

Some side effects of Talacen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to acetaminophen / pentazocine: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking acetaminophen / pentazocine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using acetaminophen and pentazocine and call your doctor at once if you have a serious side effect such as:

• fast heart rate;

• weak or shallow breathing, slow heartbeat;

• feeling like you might pass out;

• confusion, hallucinations, unusual thoughts or behavior;

• severe headache, ringing in your ears, anxiety, chest pain;

• seizure (convulsions);

• easy bruising or bleeding; or

• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of acetaminophen / pentazocine may include:

• feeling dizzy or drowsy;

• mild nausea, vomiting, upset stomach, constipation, diarrhea;

• dry mouth; or

• blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to acetaminophen / pentazocine: oral tablet

General

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

Cardiovascular

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.

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.

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.

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. Serious skin reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported with pentazocine.

Gastrointestinal

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.

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.

Hepatic

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.

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.

Hematologic

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

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.

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.

Renal

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.

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

Respiratory

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

Psychiatric

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

Other

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

Genitourinary

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

Ocular

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

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