Iso-Acetazone Side Effects

Generic name: acetaminophen / dichloralphenazone / isometheptene mucate

Note: This document contains side effect information about acetaminophen / dichloralphenazone / isometheptene mucate. Some of the dosage forms listed on this page may not apply to the brand name Iso-Acetazone.

Some side effects of Iso-Acetazone 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 / dichloralphenazone / isometheptene mucate: oral capsule

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

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

• low fever with nausea, stomach pain, and loss of appetite;

• dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fast or uneven heart rate;

• easy bruising or bleeding, unusual weakness; or

• fever, chills, sore throat, body aches, flu symptoms.

Less serious side effects of acetaminophen / dichloralphenazone / isometheptene mucate may include:

• dizziness, drowsiness;

• mild nausea; or

• mood changes.

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 / dichloralphenazone / isometheptene mucate: oral capsule

Hypersensitivity

Transient dizziness and skin rash can usually be eliminated by reducing the dose of acetaminophen/dichloralphenazone/isometheptene.

Hypersensitivity side effects including transient dizziness and skin rash have been reported with the use of acetaminophen/dichloralphenazone/isometheptene. Hypersensitivity reactions, including anaphylaxis and fixed drug eruptions have been reported rarely in association with acetaminophen use.

Hepatic

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.

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.

Cases of acute pancreatitis have been reported rarely with the use of acetaminophen.

Hepatic side effects including severe and sometimes fatal dose dependent hepatitis have been reported with the use of acetaminophen in alcoholic patients. Hepatotoxicity has been increased during fasting.

Gastrointestinal

Gastrointestinal side effects have been rare with the use of acetaminophen except in alcoholics and after overdose.

Renal

Renal side effects including acute tubular necrosis and interstitial nephritis have been rare with the use of acetaminophen. Adverse renal effects have been most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.

Acute tubular necrosis with acetaminophen use 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 as well.

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 pills per day.

Hematologic

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen have been reported. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.

Dermatologic

Dermatologic side effects including erythematous skin rashes associated with acetaminophen have been reported rarely. Acetaminophen associated bullous erythema and purpura fulminans have also been reported.

Respiratory

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

Cardiovascular

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

Two cases 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.

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