Zodryl DAC Side Effects
Generic Name: chlorpheniramine / codeine / pseudoephedrine
Note: This document contains side effect information about chlorpheniramine / codeine / pseudoephedrine. Some of the dosage forms listed on this page may not apply to the brand name Zodryl DAC.
Some side effects of Zodryl DAC 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 chlorpheniramine / codeine / pseudoephedrine: liquid
Other dosage forms:
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking chlorpheniramine / codeine / pseudoephedrine:
Constipation; dizziness; drowsiness; dry mouth, throat, or nose; excitement; nausea; stomach upset; thickening or mucus in nose or throat; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; flushing or redness of face; severe drowsiness; trouble breathing; vision changes.
For Healthcare Professionals
Applies to chlorpheniramine / codeine / pseudoephedrine: oral elixir, oral liquid
Nearly all patients treated with chlorpheniramine experience drowsiness. This drowsiness may subside in some patients with extended use. Patients should be warned against driving, as well as concomitant ingestion of alcohol and other sedative-hypnotic drugs, while taking chlorpheniramine.
Few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of chlorpheniramine extended over a period of 3 to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms.
Opioids may result in psychotic symptoms in some patients.
One retrospective study of elderly patients who sustained a hip fracture suggested that the relative risk of hip fracture was 1.6 in patients using codeine compared to age-matched non-users.
Central nervous system side effects of chlorpheniramine have included CNS depression which commonly occurs with chlorpheniramine administration, resulting in drowsiness in 75% or greater of treated patients. Dyskinesias have rarely been reported following chronic use of chlorpheniramine. 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. Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.
Other side effects of codeine have included withdrawal symptoms after either abrupt cessation or fast tapering of narcotic analgesics, including codeine, and have included agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting and sweating.
Hypotension is rare and has been reported most frequently with high doses of codeine.
Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.
One report evaluated the effect with 60 mg of pseudoephedrine on individuals in a hyperbaric chamber at 1 atmosphere (simulated scuba dive to 66 feet of sea water). Pseudoephedrine and depth (simulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.
Cardiovascular side effects of chlorpheniramine have included hypotension, tachycardia, and palpitations. Cardiovascular adverse effects of codeine have included hypotension and dizziness. Cardiovascular side effects of pseudoephedrine have included tachycardia. Some patients have developed hypertension and/or arrhythmias.
Gastrointestinal side effects of chlorpheniramine have included dry mouth and constipation due to its anticholinergic effect. This may occur in up to one-third of treated patients. Gastrointestinal side effects of codeine have included nausea, vomiting, and constipation. Severe constipation and ileus resulting in colonic perforation have also been reported. Four cases of acute pancreatitis have been reported. Gastrointestinal side effects of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat have occurred in up to 15% of patients.
Genitourinary side effects of chlorpheniramine have included dysuria, urinary hesitancy, and a decrease in urine flow. In rare cases, the anticholinergic effect of chlorpheniramine may precipitate acute urinary retention. Genitourinary side effects of codeine have included urinary retention.
Ocular effects of chlorpheniramine have included blurred vision, diplopia, and dry eyes due to anticholinergic effects.
A fatal case of agranulocytosis has been reported in a patient taking chlorpheniramine, pseudoephedrine, acetaminophen, dextromethorphan, phenylpropanolamine, and aspirin. Chlorpheniramine was felt to be the cause.
Hematologic adverse effects of chlorpheniramine have included bone marrow suppression, thrombocytopenia, and aplastic anemia.
Hypersensitivity side effects of pseudoephedrine have included fixed drug eruptions.
Dermatologic side effects of codeine have included rash. Codeine-induced rash may be related to direct stimulation of histamine release. There are also case reports of severe scarlatiniform eruptions.
Acute renal failure (which may respond to naloxone therapy) has been reported in association with codeine therapy.
Immunologic side effects of codeine have included one study of a patient with exercise-induced anaphylaxis and three control subjects. This study found a correlation between codeine wheal size and recent exercise.
The adverse effects of codeine may be more likely and more severe in patients with liver and renal disease.
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