Codeine Phosphate-Promethazine HCl Side Effects
Generic Name: codeine / promethazine
Note: This page contains information about the side effects of codeine / promethazine. Some of the dosage forms included on this document may not apply to the brand name Codeine Phosphate-Promethazine HCl.
Not all side effects for Codeine Phosphate-Promethazine HCl may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to codeine / promethazine: oral syrup
In addition to its needed effects, some unwanted effects may be caused by codeine / promethazine. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking codeine / promethazine:Incidence not known
- Abdominal or stomach pain
- bluish lips or skin
- clay-colored stools
- cold sweats
- dark urine
- decrease in the frequency of urination
- decrease in the urine volume
- difficult or troubled breathing
- difficulty in passing urine (dribbling)
- dizziness, faintness, or lightheadedness when getting up from lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- feeling of warmth
- high fever
- hives or welts
- increased sweating
- irregular, fast or slow, or shallow breathing
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- loss of bladder control
- noisy breathing
- not breathing
- painful urination
- pale or blue lips, fingernails, or skin
- rectal bleeding
- redness of the face, neck, arms, and occasionally, upper chest
- redness of the skin
- seeing, hearing, or feeling things that are not there
- severe muscle stiffness
- shakiness in the legs, arms, or hands
- shortness of breath
- tightness in the chest
- trembling or shaking of the hands or feet
- unpleasant breath odor
- unusual tiredness or weakness
- unusually pale skin
- vomiting of blood
- yellow eyes or skin
If any of the following symptoms of overdose occur while taking codeine / promethazine, get emergency help immediately:Symptoms of overdose
- Cold, clammy skin
- dry mouth
- irregular heartbeat
- no blood pressure or pulse
- no muscle tone or movement
- pinpoint pupils (black part of the eye)
- stopping of the heart
Some of the side effects that can occur with codeine / promethazine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:Incidence not known
- Bad dreams
- blurred or loss of vision
- confusion as to time, place, or person
- continuing ringing or buzzing or other unexplained noise in the ears
- difficulty having a bowel movement (stool)
- disturbed color perception
- double vision
- false or unusual sense of well-being
- halos around lights
- hearing loss
- holding false beliefs that cannot be changed by fact
- increased sensitivity of the skin to sunlight
- night blindness
- overbright appearance of lights
- redness or other discoloration of the skin
- relaxed and calm
- severe sunburn
- trouble sleeping
- tunnel vision
- unusual excitement, nervousness, or restlessness
For Healthcare Professionals
Applies to codeine / promethazine: oral syrup
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 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 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 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 side effects of codeine have included urinary retention.
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 side effects of codeine have included acute renal failure (which may respond to naloxone therapy).
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 reactions have included rare reports of rash, pruritus, hypotension, photosensitivity, and tachycardia.
Hematologic effects of promethazine have included rare cases of neutropenia.
The adverse effects of codeine may be more likely and more severe in this patient with liver and renal disease.
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