Comtrex Deep Chest Cold Side Effects

Generic name: acetaminophen / guaifenesin

Note: This document contains side effect information about acetaminophen / guaifenesin. Some of the dosage forms listed on this page may not apply to the brand name Comtrex Deep Chest Cold.

Some side effects of Comtrex Deep Chest Cold 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 / guaifenesin: oral powder for reconstitution, oral tablet

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

Stop using the medicine and call your doctor at once if you have:

• mood changes, severe dizziness or anxiety, feeling like you might pass out;

• severe headache;

• fever; or

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

Common side effects may include:

• sleep problems (insomnia); or

• feeling nervous, restless, or anxious.

Less serious side effects are more likely, and you may have none at all.

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 / guaifenesin: oral liquid, oral powder for reconstitution, oral tablet

Hepatic

Hepatic side effects of acetaminophen have included severe and sometimes fatal dose dependent hepatitis 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.

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.

Dermatologic

Dermatologic side effects of acetaminophen have included rare reports of erythematous skin rashes. Acetaminophen associated bullous erythema and purpura fulminans have also been reported.

Dermatologic side effects of guaifenesin have included rare reports of rash.

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.

Gastrointestinal side effects of acetaminophen have included rare cases of acute pancreatitis.

Gastrointestinal side effects of guaifenesin have included stomach upset and vomiting with higher than recommended doses. Doses recommended for expectoration have rarely been associated with gastrointestinal upset.

Nervous system

Nervous system side effects of guaifenesin have occasionally included dizziness and headache.

Hematologic

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

Renal

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 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.

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

Hypersensitivity

Hypersensitivity side effects of acetaminophen have included rare reports of anaphylaxis and fixed drug eruptions.

Cardiovascular

Cardiovascular side effects of acetaminophen have included two cases of hypotension.

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.

Respiratory

Respiratory side effects of acetaminophen have included a case of eosinophilic pneumonia.

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