Codeine and guaifenesin

You should not take this medicine if you are allergic to codeine or guaifenesin.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Ask a doctor before giving this medicine to a child younger than 12 years old.

Medicines that contain codeine should not be used in anyone under 18 who recently had surgery to remove the tonsils or adenoids.

To make sure codeine and guaifenesin is safe for you, tell your doctor if you have ever had:

• a cough with mucus;

• asthma, COPD, or other breathing disorder;

• blockage in your digestive tract (stomach or intestines);

• a head injury or brain tumor;

• low blood pressure; or

• drug or alcohol addiction.

If you use codeine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby. Do not breast-feed.

Applies to codeine / guaifenesin: oral capsule, oral liquid, oral syrup, oral tablet

General

The more commonly reported adverse effects of codeine include nausea, vomiting, and diarrhea. Guaifenesin is generally well tolerated.

Nervous system

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

Cardiovascular

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

Gastrointestinal

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

Guaifenesin:
Frequency not reported: Abdominal pain (upper), diarrhea, nausea, vomiting[Ref]

Genitourinary

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

Dermatologic

Codeine-induced rash may be related to direct stimulation of histamine release.[Ref]

Codeine:
Frequency not reported: Rash

Guaifenesin:
Frequency not reported: Rash[Ref]

Hypersensitivity

Codeine
Frequency not reported: Pruritus, giant urticaria, angioneurotic edema, laryngeal edema

Guaifenesin:
Frequency not reported: Hypersensitivity reactions (pruritus, urticaria)

Ocular

Codeine
Frequency not reported: Visual disturbances

Psychiatric

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

Respiratory

Codeine:
Frequency not reported: Respiratory depression[Ref]

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]

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