Acetaminophen / hydrocodone Side Effects

Some side effects of acetaminophen / hydrocodone 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 / hydrocodone: oral capsule, oral elixir, oral liquid, oral solution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking acetaminophen / hydrocodone: 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, fear, 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 of acetaminophen / hydrocodone may include:

• anxiety, dizziness, drowsiness;

• mild nausea, vomiting, upset stomach, constipation;

• headache, mood changes;

• blurred vision;

• ringing in your ears; 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 / hydrocodone: oral capsule, oral elixir, oral liquid, oral solution, oral tablet

General

The adverse effects of hydrocodone are generally similar to the adverse effects observed with other narcotic analgesics. Acetaminophen is generally well-tolerated when administered in therapeutic doses.

Nervous system

One study has suggested that the respiratory depression caused by hydrocodone may be of benefit in the treatment of dyspnea related to chronic obstructive pulmonary disease and restrictive lung disease. However, the potential for the precipitation of respiratory insufficiency makes such use of hydrocodone hazardous and such use should be undertaken, if at all, only with extreme caution.

Nervous system side effects of hydrocodone include mental depression, dizziness, lightheadedness, respiratory depression (which is sometimes fatal), stupor, delirium, somnolence, agitation, and dysphoria.

Other

Other side effects have included withdrawal symptoms, after either abrupt cessation or fast tapering of narcotic analgesics. Such symptoms may include agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting, and sweating.

Hepatic

Hepatic side effects 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.

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 hydrocodone may be more likely and more severe in patients with liver disease.

Gastrointestinal

Gastrointestinal side effects with the use of acetaminophen are rare except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely.

Gastrointestinal side effect including nausea, vomiting, constipation, and dry mouth are relatively common effects of narcotic analgesics.

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.

Genitourinary

Genitourinary side effects including ureteral spasm, spasm of vesicle sphincters, and urinary retention have been reported.

Dermatologic

Dermatologic side effects including narcotic-induced rashes have been reported. 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.

Renal

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

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases.

The adverse effects of hydrocodone may be more likely and more severe in patients with renal insufficiency.

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.

Hypersensitivity

Hypersensitivity side effects to acetaminophen have been reported rarely.

Respiratory

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

Metabolic

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.

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

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