Talacen Side Effects

Generic Name: acetaminophen / pentazocine

Note: This page contains side effects data for the generic drug acetaminophen / pentazocine. It is possible that some of the dosage forms included below may not apply to the brand name Talacen.

It is possible that some side effects of Talacen may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to acetaminophen / pentazocine: oral tablet

As well as its needed effects, acetaminophen / pentazocine may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking acetaminophen / pentazocine, check with your doctor immediately:

Rare
  • Back, leg, or stomach pains
  • black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • chills
  • cough or hoarseness
  • dark urine
  • decrease in the frequency of urination
  • decrease in urine volume
  • diarrhea
  • difficult or troubled breathing
  • difficulty in passing urine (dribbling)
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fever
  • fever with or without chills
  • general body swelling
  • general feeling of tiredness or weakness
  • headache
  • hives
  • irregular, fast or slow, or shallow breathing
  • itching
  • joint or muscle pain
  • loss of appetite
  • lower back or side pain
  • nausea or vomiting
  • nosebleeds
  • painful or difficult urination
  • pale or blue lips, fingernails, or skin
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • skin rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling or puffiness of the face
  • swollen glands
  • tightness in the chest
  • trembling or shaking of the hands or feet
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • wheezing
  • yellowing of the eyes or skin
Incidence not known
  • Blood in the urine
  • bloody nose
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • heavier menstrual periods
  • pinpoint red spots on the skin
  • redness of the face, neck, arms, and occasionally, upper chest
  • sweating

If any of the following symptoms of overdose occur while taking acetaminophen / pentazocine, get emergency help immediately:

Symptoms of overdose
  • Abdominal or stomach pain or tenderness
  • bleeding gums
  • bloody or cloudy urine
  • blurred vision
  • clay-colored stools
  • cold sweats
  • confusion
  • cool, pale skin
  • decreased appetite
  • depression
  • drowsiness
  • fear or nervousness
  • increased hunger
  • muscle tremors
  • nightmares
  • rapid, deep breathing
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • seizures
  • slurred speech
  • stomach cramps
  • strange thoughts
  • sudden decrease in the amount of urine
  • sugar in the urine
  • swelling of the feet or lower legs
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • vomiting of blood
  • weight loss

Some acetaminophen / pentazocine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Rare
  • Continuing ringing or buzzing or other unexplained noise in the ears
  • excitement
  • hearing loss
  • hives or welts
  • irritability
  • redness of the skin
Incidence not known
  • Confusion about identity, place, and time
  • constipation
  • difficulty in focusing the eyes
  • disturbed dreams
  • drowsiness
  • false or unusual sense of well-being
  • relaxed and calm feeling
  • sleepiness
  • sleeplessness
  • trouble sleeping
  • unable to sleep
  • weakness

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

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

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

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]

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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