Magnacet Side Effects

Generic name: acetaminophen / oxycodone

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

Some side effects of Magnacet 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 / oxycodone: oral capsule, oral solution, oral tablet

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

Call your doctor at once if you have any of these serious side effects:

• shallow breathing, slow heartbeat;

• feeling light-headed, fainting;

• confusion, unusual thoughts or behavior;

• seizure (convulsions);

• problems with urination; or

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

Less serious side effects include:

• feeling dizzy or drowsy;

• mild nausea, vomiting, upset stomach, constipation;

• blurred vision; or

• dry mouth.

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 / oxycodone: oral capsule, oral solution, oral tablet

General

Psychosis has also been reported during withdrawal from oxycodone.

In general, acetaminophen is well tolerated when administered in therapeutic doses. Oxycodone may be habit forming. Withdrawal symptoms after either abrupt cessation or fast tapering may occur and include agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, piloerection, blurred vision, vomiting, and sweating.

Dermatologic

Dermatologic side effects including general erythematous skin rashes associated with acetaminophen have been reported, but are rare. Cases of bullous erythema and purpura fulminans associated with acetaminophen have been reported. Oxycodone may produce pruritus.

Gastrointestinal

Gastrointestinal side effects with acetaminophen are rare except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely. Nausea, vomiting, and constipation occur commonly with oxycodone.

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.

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.

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.

Hepatic side effects 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

Hypersensitivity

Hypersensitivity side effects including anaphylaxis and fixed drug eruptions have been reported rarely in association with acetaminophen use.

Nervous system

Severe adverse effects of oxycodone, such as respiratory depression, can be treated with the opioid antagonist, naloxone. (The usual adult dose of naloxone is 1 to 2 mg every 5 minutes as necessary to a maximum of 10 mg. The dose is usually administered intravenously, but in an emergency may be given intramuscularly, subcutaneously, or sublingually.)

Nervous system side effects with oxycodone containing products are common and include drowsiness, sedation, dizziness, and lightheadedness. Respiratory depression has also been reported.

Psychiatric

Psychiatric side effects of oxycodone reported include paranoia, psychosis, and hallucinations.

Renal

Acetaminophen related acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the 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.

Renal side effects of acetaminophen are rare and include acute tubular necrosis and interstitial nephritis. Additional adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.

Respiratory

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

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.

Cardiovascular side effects have included at least two cases of hypotension which have been reported following the administration of acetaminophen.

Metabolic

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

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.

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