Zodryl DAC

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.
• Hard stools (constipation).
• Upset stomach or throwing up.
• Sweating a lot.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to chlorpheniramine / codeine / pseudoephedrine: oral liquid

Applies to chlorpheniramine / codeine / pseudoephedrine: oral elixir, oral liquid

General

The more commonly expected adverse effects include nausea, vomiting, constipation, blurred vision, confusion, dizziness, and headache.[Ref]

Respiratory

Codeine:
Frequency not reported: Respiratory depression, dryness of the pharynx and respiratory passages, laryngismus, atelectasis, wheezing, troubled breathing, hiccups[Ref]

Respiratory depression has been associated with antitussive use of codeine in young children. Respiratory depression and death have occurred in children who received codeine in the postoperative period following tonsillectomy and/or adenoidectomy. Further investigation has shown these patients to be ultra-rapid metabolizers of codeine. Children with obstructive sleep apnea who are treated with codeine appear to be particularly sensitive to the respiratory depressant effects of codeine.[Ref]

Cardiovascular

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.[Ref]

Codeine or Chlorpheniramine:
Frequency not reported: Fast, or slow heartbeat, hypertension, hypotension, orthostatic hypotension, palpitations, shock-like state, syncope

Pseudoephedrine:
Frequency not reported: Tachycardia, palpitations, cardiac arrhythmias, hypertension, impaired circulation to the extremities, coronary artery spasm, chest pain[Ref]

Gastrointestinal

Codeine or Chlorpheniramine:
Frequency not reported: Nausea, vomiting, constipation, abdominal distension, abdominal pain, acute pancreatitis, dry mouth, dyspepsia, epigastric distress, diarrhea, gastro-esophageal reflux, gastrointestinal hypomotility

Pseudoephedrine:
Frequency not reported: Nausea, vomiting, dry mouth[Ref]

Psychiatric

Codeine:
Frequency not reported: Drug dependence, confusion, depression, euphoria, false sense of well-being, excitability, nervousness, agitation, restlessness, insomnia, irritability

Pseudoephedrine:
Frequency not reported: Hallucinations (particularly in children), anxiety, excitability, insomnia[Ref]

Nervous system

Codeine or Chlorpheniramine:
Frequency not reported: Weakness, dizziness, drowsiness, sedation, headache, facial dyskinesia, lightheadedness, somnolence, dyskinesia, tremor

Pseudoephedrine:
Frequency not reported: Restlessness, dizziness, weakness, headache, drowsiness, tremor[Ref]

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.[Ref]

Genitourinary

Codeine or Chlorpheniramine:
Frequency not reported: Ureteral spasm, urinary retention, dysuria, urinary frequency, urinary hesitancy, irritative bladder symptom

Pseudoephedrine:
Frequency not reported: Urinary retention[Ref]

Hypersensitivity

Codeine or Chlorpheniramine:
Frequency not reported: Allergic laryngospasm, nasal stuffiness, bronchospastic allergic reaction, hives, itching, swelling of face[Ref]

Dermatologic

Codeine or Chlorpheniramine:
Frequency not reported: Redness or flushing of face, skin rash, pruritus, erythema, urticaria, excessive perspiration, dermatitis

Pseudoephedrine:
Frequency not reported: Fixed drug eruption in the form of erythematous nodular patches, rash[Ref]

Endocrine

Codeine or Chlorpheniramine:
Frequency not reported: Decreased lactation, early menses, gynecomastia, increased libido, pheochromocytoma stimulation[Ref]

Metabolic

Codeine or Chlorpheniramine:
Frequency not reported: Changes in glucose utilization, glycosuria, hypoglycemia, increased appetite, loss of appetite[Ref]

Ocular

Codeine or Chlorpheniramine:
Frequency not reported: Blurred vision, diplopia, visual disturbances, hypermetropia, lacrimation increased, mydriasis, photophobia

Pseudoephedrine:
Frequency not reported: Angle-closure glaucoma[Ref]

Other

Codeine or Chlorpheniramine:
Frequency not reported: Asthenia, feeling of relaxation, unusual tiredness, labyrinthitis, tinnitus, vertigo[Ref]

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.