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Codeine / promethazine Side Effects

For the Consumer

Applies to codeine / promethazine: oral syrup

Along with its needed effects, codeine / promethazine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking codeine / promethazine:

Incidence not known
  • Abdominal or stomach pain
  • bluish lips or skin
  • chills
  • clay-colored stools
  • cold sweats
  • confusion
  • convulsions
  • cough
  • dark urine
  • decrease in the frequency of urination
  • decrease in the urine volume
  • diarrhea
  • difficult or troubled breathing
  • difficulty in passing urine (dribbling)
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up from lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • fever
  • headache
  • high fever
  • hives or welts, itching, or rash
  • 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
  • nausea
  • 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
  • sweating
  • tightness in the chest
  • tiredness
  • 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

Get emergency help immediately if any of the following symptoms of overdose occur while taking codeine / promethazine:

Symptoms of overdose
  • Cold, clammy skin
  • dry mouth
  • fainting
  • irregular heartbeat
  • no blood pressure or pulse
  • no muscle tone or movement
  • pinpoint pupils (black part of the eye)
  • stopping of the heart
  • unconsciousness

Some side effects of codeine / promethazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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
  • drowsiness
  • 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
  • sleepiness
  • trouble sleeping
  • tunnel vision
  • unusual excitement, nervousness, or restlessness
  • vomiting

For Healthcare Professionals

Applies to codeine / promethazine: oral syrup

General

The more commonly reported adverse effects have included nausea, vomiting, constipation, blurred vision, confusion, and dizziness.[Ref]

Respiratory

Codeine:
Frequency not reported: Respiratory depression

Promethazine:
Frequency not reported: Asthma, nasal stuffiness, respiratory depression, apnea[Ref]

Concomitant administration of promethazine with other respiratory depressants has been associated with respiratory depression, including fatalities. Postmarketing cases in pediatric patients less than 2 years of age has been reported with a wide range of weight-based doses. Respiratory depression has been associated with antitussive use of codeine in young children.

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]

Nervous system

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

Promethazine:
Frequency not reported: Drowsiness, sedation, somnolence, extra-pyramidal symptoms, torticollis, tongue protrusion, incoordination, tremors, seizures, neuroleptic malignant syndrome, paradoxical reactions[Ref]

Promethazine use has resulted in paradoxical reactions described as hyperexcitability and abnormal movements. This has occurred following 1 dose and in some patients accompanied by respiratory depression, nightmares, delirium, and agitated behavior.[Ref]

Psychiatric

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

Promethazine:
Frequency not reported: Confusion, disorientation, euphoria, nervousness, insomnia, excitation, catatonic-like states, hysteria, hallucinations[Ref]

Gastrointestinal

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

Promethazine:
Frequency not reported: Dry mouth, nausea, vomiting[Ref]

Patients with chronic ulcerative colitis may experience increased colonic motility, while patients with acute ulcerative colitis have experienced toxic dilation with codeine use.[Ref]

Hypersensitivity

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

Promethazine:
Frequency not reported: Angioneurotic edema[Ref]

Cardiovascular

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

Promethazine:
Frequency not reported: Increased or decreased blood pressure, tachycardia, bradycardia, faintness[Ref]

Genitourinary

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

Dermatologic

Promethazine:
Frequency not reported: Dermatitis, photosensitivity, urticaria[Ref]

Hematologic

Promethazine:
Frequency not reported: Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis[Ref]

Hepatic

Promethazine:
Frequency not reported: Cholestatic jaundice[Ref]

Metabolic

Promethazine:
Frequency not reported: Hyperglycemia

Ocular

Codeine
Frequency not reported: Visual disturbances

Promethazine:
Frequency not reported: Blurred vision, oculogyric crisis, diplopia[Ref]

Other

Promethazine:
Frequency not reported: Lassitude, tinnitus, fatigue[Ref]

References

1. "Product Information. Codeine Phosphate-Promethazine HCl (codeine-promethazine)." Par Pharmaceutical Inc (formerly Qualitest Pharmaceuticals Inc), Huntsville, AL.

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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