Codeine / promethazine Side Effects

Some side effects of codeine / promethazine 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 / promethazine: oral syrup

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

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

• restless muscle movements in your eyes, tongue, jaw, or neck, tremor (uncontrolled shaking);

• shallow breathing, slow heartbeat;

• feeling like you might pass out;

• jaundice (yellowing of the skin or eyes);

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

• seizure (convulsions);

• urinating less than usual or not at all; or

• very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats, fainting.

Less serious side effects of codeine / promethazine may include:

• dizziness, drowsiness, sleepiness;

• feeling restless, nervous, or anxious;

• blurred vision, ringing in your ears;

• constipation, mild nausea or vomiting;

• warmth, redness, or tingly feeling under your skin;

• sleep problems (insomnia);

• increased sweating;

• dry mouth; or

• mild skin 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 / promethazine: oral syrup

Nervous system

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 promethazine are common and include excessive sedation, drowsiness, fatigue, paradoxical excitation, and decreased motor coordination. Extrapyramidal effects (including oculogyric crises, torticollis and tongue protrusion), encephalitic symptoms, convulsions, and psychosis have been rarely reported.

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.

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. Other side effects of promethazine have rarely included the neuroleptic malignant syndrome.

Fever, altered consciousness, autonomic dysfunction, and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome is associated with a case fatality rate of about 20%. Immediate discontinuation of promethazine and intensive monitoring and supportive care are indicated.

Cardiovascular

Cardiovascular adverse effects of codeine have included hypotension and dizziness. Cardiovascular effects of promethazine have included rarely observed tachycardia, bradycardia, and transient hypotension. Prolongation of the QT interval, heart block, and malignant arrhythmias have been reported in association with other phenothiazines.

Gastrointestinal

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

Genitourinary

Genitourinary side effects of codeine have included urinary retention.

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.

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. Immunologic side effects of promethazine have included rare reports of a systemic lupus erythematosus syndrome.

Hypersensitivity

Hypersensitivity reactions have included rare reports of rash, pruritus, hypotension, photosensitivity, and tachycardia.

Hematologic

Hematologic effects of promethazine have included rare cases of neutropenia.

General

The adverse effects of codeine may be more likely and more severe in this patient with liver and renal disease.

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