Codeine / guaifenesin / pseudoephedrine Side Effects

Some side effects of codeine / guaifenesin / pseudoephedrine 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 codeine / guaifenesin / pseudoephedrine: oral liquid, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking codeine / guaifenesin / pseudoephedrine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• fast or uneven heart rate;

• hallucinations;

• confusion, severe dizziness or drowsiness, feeling like you might pass out;

• tremor, seizure (convulsions);

• pain or numbness in the arms or legs;

• severe stomach cramps or constipation;

• weak or shallow breathing;

• urinating less than usual or not at all; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, confusion, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects of codeine / guaifenesin / pseudoephedrine may include:

• dizziness, drowsiness;

• constipation;

• blurred vision;

• feeling nervous, restless, or anxious; or

• sleep problems (insomnia).

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 / guaifenesin / pseudoephedrine: oral liquid, oral tablet

General

Guaifenesin is generally well tolerated.

Nervous system

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.

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 guaifenesin have included dizziness and headache. 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

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.

Cardiovascular

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.

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 (stimulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.

Gastrointestinal

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 guaifenesin have included upset stomach and vomiting with higher than recommended doses. Doses recommended for expectoration are rarely associated with gastrointestinal upset. 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

Genitourinary side effects of codeine have included urinary retention.

Hypersensitivity

Hypersensitivity side effects of pseudoephedrine have included fixed drug eruptions.

Dermatologic

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. Dermatologic side effects of guaifenesin have also included rash.

Renal

Renal side effects of codeine have included acute renal failure (which may respond to naloxone therapy).

Immunologic

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.

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