Codeine Side Effects

Some side effects of codeine 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: oral solution, oral tablet

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

Seek emergency medical attention if a child taking this medication has any of the following life-threatening side effects: noisy breathing, sighing, slow breathing with long pauses between breaths; being unusually sleepy or hard to wake up; blue colored lips.

Call your doctor at once if you have a serious side effect such as:

• slow heart rate, weak pulse, fainting, shallow breathing;

• feeling like you might pass out;

• confusion, agitation, hallucinations, unusual thoughts or behavior;

• feelings of extreme happiness or sadness;

• seizure (convulsions); or

• problems with urination.

Less serious side effects include:

• feeling dizzy or drowsy;

• nausea, vomiting, stomach pain;

• constipation;

• sweating; or

• mild itching or rash.

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: compounding powder, injectable solution, oral solution, oral tablet

General

The side effects have been more likely and more severe in patients with liver and/or renal disease.

Nervous system

Nervous system side effects have included mental and respiratory depression, stupor, delirium, somnolence, and dysphoria. An increased risk of falls and hip fractures has also been associated with codeine therapy, particularly in the elderly. A case of seizures has been reported with the use of intravenous codeine phosphate.

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 nonusers.

Other

Other side effects including withdrawal symptoms after either abrupt cessation or fast tapering of narcotic analgesics have been reported. These withdrawal symptoms have included agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting, and sweating.

Cardiovascular

Hypotension is rare and has been reported most frequently with high doses.

Cardiovascular side effects have included hypotension and dizziness.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and constipation have been reported frequently. Severe constipation and ileus resulting in colonic perforation have also been reported. Four cases of acute pancreatitis have been reported.

Genitourinary

Genitourinary side effects including urinary retention have been reported.

Dermatologic

Dermatologic side effects including rashes, severe scarlatiniform eruptions, and generalized dermatitis have been reported rarely.

Codeine induced rashes may be related to direct stimulation of histamine release.

Renal

Renal side effects including acute renal failure (which may respond to naloxone therapy) have been reported in association with codeine therapy.

Immunologic

Immunologic side effects have included one study of a patient with exercise induced anaphylaxis and three control subjects which found a correlation between codeine wheal size and recent exercise.

Hypersensitivity

Hypersensitivity side effects including a case of codeine phosphate induced hypersensitivity syndrome have been reported.

Ocular

Ocular side effects including a temporary 26% decrease in pupil diameter following the administration of intravenous codeine have been reported.

Respiratory

Respiratory side effects have included respiratory depression.

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