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Balacet Side Effects

Generic name: acetaminophen / propoxyphene

Note: This document provides detailed information about Balacet Side Effects associated with acetaminophen / propoxyphene. Some dosage forms listed on this page may not apply specifically to the brand name Balacet.

Applies to acetaminophen/propoxyphene: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol, has occurred, and may be fatal within the first hour.

Many of the fatalities have occurred in patients with previous histories of emotional disturbances or suicidal ideation/attempts and/or concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs.

Do not prescribe propoxyphene for patients who are suicidal or have a history of suicidal ideation.

The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors leading to enhanced propoxyphene plasma levels; monitor patients closely and adjust dosages if necessary in patients receiving any CYP3A4 inhibitor concomitantly.

Common side effects of Balacet

Some side effects of acetaminophen / propoxyphene 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 side effects

  • relaxed and calm feeling

Incidence not known

  • abnormal behavior
  • blurred or loss of vision
  • constipation
  • diarrhea
  • disturbed color perception
  • double vision
  • false or unusual sense of well-being
  • halos around lights
  • indigestion
  • muscular pain, tenderness, wasting, or weakness
  • night blindness
  • nightmares or unusually vivid dreams
  • overbright appearance of lights
  • seeing, hearing, or feeling things that are not there
  • swelling of the eye
  • tunnel vision

Serious side effects of Balacet

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

Rare side effects

  • abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • dizziness
  • fever
  • headache
  • itching
  • loss of appetite
  • nausea
  • rash
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting of blood
  • yellow eyes or skin

Incidence not known

  • bloating
  • bloody or black, tarry stools
  • bloody or cloudy urine
  • change in consciousness
  • chest pain or discomfort
  • confusion
  • cough
  • decreased urine output
  • difficult or troubled breathing
  • dilated neck veins
  • drowsiness
  • extreme fatigue
  • fainting
  • fast, slow, pounding, or irregular heartbeat or pulse
  • fever with or without chills
  • general feeling of discomfort or illness
  • hives
  • hoarseness
  • irregular, fast, slow, or shallow breathing
  • itching
  • joint pain, stiffness, or swelling
  • light-colored stools
  • loss of consciousness
  • low blood pressure or pulse
  • muscle aches and pains
  • muscle tremors
  • pain or discomfort in the arms, jaw, back, or neck
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale or blue lips, fingernails, or skin
  • rapid, deep breathing
  • redness of the skin
  • restlessness
  • right upper stomach pain and fullness
  • runny nose
  • severe stomach pain
  • shakiness and unsteady walk
  • shivering
  • shortness of breath
  • sore throat
  • stomach cramps
  • sudden decrease in the amount of urine
  • sweating
  • swelling of the eyelids, face, fingers, lips, hands, lower legs, or feet
  • thoughts of suicide
  • tightness in the chest
  • trouble sleeping
  • troubled breathing or swallowing
  • unconsciousness
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • very slow breathing
  • very slow heartbeat
  • vomiting of blood or material that looks like coffee grounds
  • weight gain
  • wheezing

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

Symptoms of overdose

Managing side effects (general information)

For healthcare professionals

Applies to acetaminophen / propoxyphene: oral tablet.

General adverse events

General side effects including drug tolerance and influenza type illness have been reported with the use of propoxyphene.

Other

Other side effects including propoxyphene dependence have been reported (although the abuse liability of propoxyphene is less than that of some other narcotic analgesics). Withdrawal symptoms (after either abrupt cessation or fast tapering) have been reported to include agitation, restlessness, anxiety, insomnia, tremor, tachycardia, hallucinations, psychosis, abdominal cramps, vomiting, sweating, and seizures.

Drug toxicity, multiple drug overdose, and narcotic overdose have also been reported with propoxyphene.

Sensorineural deafness has been reported following chronic abuse and/or large doses of propoxyphene-containing compounds. Optic atrophy has been reported following overdose.[Ref]

Gastrointestinal

Gastrointestinal side effects of acetaminophen are rare, except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely with acetaminophen use. Nausea, vomiting, and constipation are relatively common effects of propoxyphene. Gastrointestinal bleeding and acute pancreatitis have also been reported with the use of propoxyphene.[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.

Elevated liver function tests, jaundice and hepatotoxicity have been reported in association with propoxyphene.

A case of ischemic colitis has been reported following an overdose of propoxyphene which was complicated by severe hypotension.[Ref]

Cardiovascular

Cardiovascular side effects of propoxyphene have included arrhythmia, bradycardia, cardiac/respiratory arrest, congestive arrest, congestive heart failure (CHF), tachycardia, myocardial infarction (MI), hypotension, decreased blood pressure, elevated heart rate, abnormal heart rate, and dizziness. A variety of arrhythmias (including heart block) have been reported most often in association with overdose.[Ref]

Some of the cardiotoxic effects reported in association with propoxyphene may be attributable to its major active metabolite, norpropoxyphene.[Ref]

Renal

Renal side effects of acetaminophen have been rare and have included acute tubular necrosis and interstitial nephritis. Cases of severe hypoglycemia have been reported in patients with chronic renal failure who received propoxyphene.[Ref]

Acute tubular necrosis associated with acetaminophen usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. Adverse acetaminophen renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.

A single case of nephrogenic diabetes insipidus has been reported following overdose of propoxyphene (however, other causes of diabetes insipidus in that patient were not rigorously excluded).

The adverse effects of propoxyphene may be more likely and more severe in patients with renal insufficiency.[Ref]

Hypersensitivity

Hypersensitivity side effects to acetaminophen have been reported rarely.

Hypersensitivity side effects to propoxyphene have also been reported.[Ref]

Genitourinary

Genitourinary side effects have included a case of retroperitoneal fibrosis in association with propoxyphene therapy.[Ref]

Hematologic

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen have been reported. Acute thrombocytopenia has also been reported as having been caused by sensitivity to acetaminophen glucuronide, the major metabolite of acetaminophen. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose. Cases of hemolytic anemia, pancytopenia, and disseminated intravascular coagulation after administration (or abuse) of propoxyphene-containing compounds have been reported rarely.[Ref]

Dermatologic

Dermatologic side effects including rashes have been reported in association with both propoxyphene and acetaminophen. Itch has also been reported with the use of propoxyphene.[Ref]

General erythematous skin rashes associated with acetaminophen have been reported, but are rare. A rare case of bullous erythema associated with acetaminophen has been reported.[Ref]

Respiratory

Respiratory side effects including a case of acetaminophen-induced eosinophilic pneumonia have been reported.

Respiratory side effects including dyspnea have been reported with the use of propoxyphene.[Ref]

Musculoskeletal

Musculoskeletal side effects including myopathy and rhabdomyolysis have been reported after chronic oral use. Fibrous myopathy has also been reported in propoxyphene-abusing patients who administer the drug via intramuscular injection.[Ref]

Hepatic

Hepatic side effects of acetaminophen including severe and sometimes fatal dose dependent hepatitis have been reported in alcoholic patients. Hepatotoxicity has been increased during fasting. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity.

Hepatic side effects of propoxyphene have included elevated liver function tests, jaundice, hepatic steatosis, hepatomegaly, hepatocellular injury, and hepatotoxicity.[Ref]

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. However, 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.

The adverse effects of acetaminophen-propoxyphene may be more likely and more severe in patients with liver disease.[Ref]

Metabolic

Metabolic side effects including metabolic acidosis have been reported following a massive overdose of acetaminophen.

Metabolic side effects including metabolic acidosis have been reported with the use of propoxyphene. Cases of severe hypoglycemia have been reported in patients with chronic renal failure.

In the case of metabolic acidosis, causality is uncertain as more than one drug was ingested. The case of metabolic acidosis followed the ingestion of 75 grams of acetaminophen, 1.95 grams of aspirin, and a small amount of a liquid household cleaner. The patient also had a history of seizures which the authors reported may have contributed to an increased lactate level indicative of metabolic acidosis.

Ocular

Ocular side effects including eye swelling and vision blurred have been reported with the use of propoxyphene.

Nervous system

Nervous system side effects of propoxyphene have included dizziness, sedation, stupor, delirium, somnolence, ataxia, coma, syncope, and respiratory depression. The sedative effects of propoxyphene have been associated with a 60% increased risk of hip fracture in elderly patients.[Ref]

Psychiatric

Psychiatric side effects including abnormal behavior, confusional state, hallucinations, and mental status change have been reported with the use of propoxyphene.

References

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More about Balacet (acetaminophen / propoxyphene)

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Further information

Balacet side effects can vary depending on the individual. 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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