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Codeine / pseudoephedrine Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 25, 2020.

For the Consumer

Applies to codeine/pseudoephedrine: oral liquid

Warning

Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

This medicine is not for use in anyone under 18.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medications, codeine can slow your breathing. Death may occur if breathing becomes too weak.

A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Stop using codeine and pseudoephedrine and call your doctor at once if you have:

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common side effects may include:

  • drowsiness;

  • blurred vision; or

  • constipation.

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 codeine / pseudoephedrine: oral capsule, oral liquid, oral syrup

General

The more commonly reported adverse effects have included nausea, vomiting, and dizziness.[Ref]

Respiratory

Codeine:

Frequency not reported: Respiratory depression[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]

Nervous system

Codeine

Frequency not reported: CNS depression, lightheadedness, dizziness, sedation, headache, convulsions, weakness

Pseudoephedrine:

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

Gastrointestinal

Codeine

Frequency not reported: Nausea, vomiting, constipation, biliary tract spasm, increased colonic motility, toxic dilation

Pseudoephedrine:

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

Patients with chronic ulcerative colitis may experience increased colonic motility, while patients with acute ulcerative colitis have experienced toxic dilation with codeine use.[Ref]

Psychiatric

Codeine

Frequency not reported: Euphoria, dysphoria, transient hallucination, disorientation

Pseudoephedrine:

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

Cardiovascular

Codeine

Frequency not reported: Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension, circulatory depression

Pseudoephedrine:

Frequency not reported: Tachycardia, palpitations, cardiac arrhythmias, hypertension, impaired circulation to the extremities[Ref]

Dermatologic

Codeine:

Frequency not reported: Rash

Pseudoephedrine:

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

Genitourinary

Codeine

Frequency not reported: Oliguria, urinary retention, antidiuretic effect

Pseudoephedrine:

Frequency not reported: Urinary retention[Ref]

Hypersensitivity

Codeine

Frequency not reported: Pruritus, giant urticaria, angioneurotic edema, laryngeal edema[Ref]

Ocular

Codeine

Frequency not reported: Visual disturbances

Pseudoephedrine:

Frequency not reported: Angle-closure glaucoma[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.