Acetaminophen / codeine Side Effects
Some side effects of acetaminophen / codeine 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 / codeine: oral liquid, oral suspension, oral tablet
Get emergency medical help if you have any of these signs of an allergic reaction while taking acetaminophen / codeine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Seek emergency medical attention if a child taking this medication has any of the following life-threatening side effects: noisy breathing, sighing, slow breathing with long pauses between breaths; being unusually sleepy or hard to wake up; blue colored lips.
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;
easy bruising or bleeding; or
nausea, stomach pain, loss of appetite, itching, 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
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 / codeine: oral capsule, oral liquid, oral suspension, oral tablet
Nervous system side effects of codeine have included mental and respiratory depression, stupor, delirium, somnolence, and dysphoria. An increased risk of falls and hip fractures has been associated with codeine therapy, particularly in the elderly.
Other side effects such as withdrawal symptoms (after either abrupt cessation or fast tapering of narcotic analgesics) have included agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting and sweating.
One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism for this side effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.
Gastrointestinal side effects of acetaminophen are rare except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely in association with acetaminophen.
Nausea, vomiting, and constipation have been reported frequently with the use of codeine. Severe constipation and ileus resulting in colonic perforation have been also reported. Four cases of acute pancreatitis have been reported.
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.
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-codeine may be more likely and more severe in patients with liver disease.
Cardiovascular side effects of codeine have included hypotension and dizziness.
Renal side effects of acetaminophen including acute tubular necrosis and interstitial nephritis have been reported rarely.
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. Acute renal failure (which responded to naloxone therapy) has also been reported in association with codeine therapy.
The adverse effects of codeine may be more likely and more severe in patients with renal insufficiency.
Hypersensitivity side effects including anaphylaxis and fixed drug eruptions have been reported rarely in association with acetaminophen use.
Genitourinary side effects including urinary retention have been reported in association with codeine use.
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.
Dermatologic side effects including rashes have been reported in association with both codeine and acetaminophen. A case of henoch-schonlein purpura has been reported in a patient receiving acetaminophen with codeine.
Codeine-induced rashes may be related to direct stimulation of histamine release. Case reports of severe scarlatiniform eruptions have also been reported in association with codeine. 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.
Respiratory side effects have included a case of acetaminophen-induced eosinophilic pneumonia.
Immunologic side effects have been reported. One study of a patient with exercise-induced anaphylaxis and three control subjects has found a correlation between codeine wheal size and recent exercise.
More acetaminophen/codeine resources
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