Notuss-PE Side Effects

Generic Name: codeine / phenylephrine

Note: This document contains side effect information about codeine / phenylephrine. Some of the dosage forms listed on this page may not apply to the brand name Notuss-PE.

For the Consumer

Applies to codeine / phenylephrine: oral liquid

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

Get emergency medical help if a child taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

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

• noisy breathing, sighing, shallow breathing;

• a slow heart rate or weak pulse;

• severe dizziness or drowsiness;

• severe restlessness or nervousness;

• severe constipation;

• pounding heartbeats or fluttering in your chest;

• painful or difficult urination; or

• little or no urinating.

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

Common side effects may include:

• mild drowsiness;

• blurred vision; or

• nausea, vomiting, diarrhea, 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 / phenylephrine: oral liquid

General

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

Respiratory

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]

Codeine:
Frequency not reported: Respiratory depression

Phenylephrine:
Frequency not reported: Respiratory distress^[Ref]

Gastrointestinal

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

Codeine
Frequency not reported: Nausea, vomiting, constipation, biliary tract spasm, increased colonic motility, toxic dilation^[Ref]

Cardiovascular

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

Phenylephrine:
Frequency not reported: Ischemia^[Ref]

Dermatologic

Codeine:
Frequency not reported: Rash^[Ref]

Hypersensitivity

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

Psychiatric

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

Phenylephrine:
Frequency not reported: Anxiety, nervousness^[Ref]

Nervous system

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

Phenylephrine:
Frequency not reported: Restlessness, dizziness, tremor, weakness^[Ref]

Genitourinary

Codeine
Frequency not reported: Oliguria, urinary retention, antidiuretic effect^[Ref]

Ocular

Codeine
Frequency not reported: Visual disturbances^[Ref]

Other

Phenylephrine:
Frequency not reported: Pain^[Ref]

Some side effects of Notuss-PE may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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