Note: This document contains side effect information about chlorpheniramine / codeine. Some dosage forms listed on this page may not apply to the brand name Tuxarin ER.
Applies to chlorpheniramine / codeine: oral suspension extended release.
Warning
Oral route (Suspension, Extended Release)
Warning: Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression, Accidental Ingestion, Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children; Medication Errors; Interactions with Drugs Affecting Cytochrome P450 3A4; Concomitant Use with Benzodiazepines or Other CNS Depressants; Neonatal Opioid Withdrawal SyndromeCodeine polistirex/chlorpheniramine polistirex exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor closely for these behaviors and conditions.Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or when used in patients at higher risk.Accidental ingestion of codeine polistirex/chlorpheniramine polistirex, especially by children, can result in a fatal overdose of codeine.Life-threatening respiratory depression and death have occurred in children who received codeine; most cases followed tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. Codeine polistirex/chlorpheniramine polistirex is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of codeine polistirex/chlorpheniramine polistirex in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.Ensure accuracy when prescribing, dispensing, and administering codeine polistirex/chlorpheniramine polistirex. Dosing errors can result in accidental overdose and death.The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex, requiring careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. Avoid the use of codeine polistirex/chlorpheniramine polistirex in patients who are taking a CYP3A4 inhibitor, CYP3A4 inducer, or 2D6 inhibitor.Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of codeine polistirex/chlorpheniramine polistirex in patients taking benzodiazepines, other CNS depressants, or alcohol. Codeine polistirex/chlorpheniramine polistirex is not recommended for use in pregnant women. Prolonged use of codeine polistirex/chlorpheniramine polistirex during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If codeine polistirex/chlorpheniramine polistirex is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Serious side effects of Tuxarin ER
Along with its needed effects, chlorpheniramine / codeine 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 chlorpheniramine / codeine:
Incidence not known
- Anxiety
- belching
- bloating
- blurred or loss of vision
- chills
- cold, clammy skin
- cold sweat
- confusion
- dark urine
- depression
- diarrhea
- difficult or painful urination
- disturbed color perception
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- double vision
- dryness or spasm of the throat
- feeling of constant movement of self or surroundings
- fever
- halos around lights
- headache
- heartburn
- increased hunger
- indigestion
- irregular, fast or slow, or shallow breathing
- loss of appetite
- nausea
- nervousness
- night blindness
- nightmares
- overbright appearance of lights
- pain in the stomach, side, or abdomen, possibly radiating to the back
- pain or discomfort in the chest, upper stomach, or throat
- pale or blue lips, fingernails, or skin
- pressure in the stomach
- pounding in the ears
- seizures
- sensation of spinning
- shakiness
- sleepiness or unusual drowsiness
- slow, fast, or irregular heartbeat
- slurred speech
- stomach discomfort, upset, or pain
- sweating
- tunnel vision
- unusual tiredness or weakness
- vomiting
- yellow eyes or skin
Other side effects of Tuxarin ER
Some side effects of chlorpheniramine / codeine 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
- Anxiety
- blistering, crusting, or irritation of the skin
- continuing ringing or buzzing or other unexplained noise in the ears
- cracked, dry, scaly skin
- dry mouth
- early menstrual periods
- face is warm or hot to touch
- false or unusual sense of well-being
- general feeling of discomfort or illness
- hearing loss
- hiccups
- increased appetite
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- irritability
- lack or loss of strength
- redness of the face
- restlessness
- skin rash, itching, redness, hives, swelling
- swelling of the breasts or breast soreness in both females and males
- trouble sleeping
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- watering of the eyes
For Healthcare Professionals
Applies to chlorpheniramine / codeine: oral liquid, oral suspension, oral suspension extended release, oral tablet, oral tablet extended release.
Cardiovascular
Frequency not reported: Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, orthostatic hypotension, palpitations, syncope, prolonged QT interval, hot flush[Ref]
Nervous system
Frequency not reported: Coma, lethargy, serotonin syndrome, ataxia, sedation, headache, facial dyskinesia, lightheadedness, tremor, tinnitus, vertigo, impaired mental and physical performance, increased intracranial pressure, seizures[Ref]
Serotonin syndrome has been reported with concomitant opioids and serotonergic drugs.[Ref]
Gastrointestinal
Frequency not reported: Abdominal pain, bowel obstruction, diarrhea, difficulty swallowing, gastro-esophageal reflux, pancreatitis, dry mouth, increase of serum amylase, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi)[Ref]
Respiratory
Frequency not reported: Respiratory depression, bronchitis, cough, dry nose, dry throat, dyspnea, nasal congestion, nasopharyngitis, thickening of bronchial secretions, tightness of chest and wheezing, upper respiratory tract infection[Ref]
Endocrine
Frequency not reported: Adrenal insufficiency, androgen deficiency[Ref]
Adrenal insufficiency has been reported with opioid use, most often following greater than one month of use. Androgen deficiency has been reported with chronic opioid use.[Ref]
Dermatologic
Frequency not reported: Flushing of face, hyperhidrosis, rash, pruritus[Ref]
Hypersensitivity
Frequency not reported: Anaphylaxis[Ref]
Ocular
Frequency not reported: Blurred vision, diplopia, miosis, visual disturbances[Ref]
General
The most common adverse events were sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, shortness of breath, and sweating.[Ref]
Other
Frequency not reported: Death, fatigue, falling injuries, neonatal opioid withdrawal syndrome, drug overdose, obscured clinical course in patients with head injuries, neonatal opioid withdrawal syndrome[Ref]
Metabolic
Frequency not reported: Decreased appetite[Ref]
Psychiatric
Frequency not reported: Agitation, anxiety, drug dependence, confusion, fear, depression, dysphoria, hallucinations, drug abuse, opioid withdrawal syndrome[Ref]
Hematologic
Frequency not reported: Agranulocytosis, aplastic anemia, thrombocytopenia
Musculoskeletal
Frequency not reported: Arthralgia, backache, muscle spasm
Genitourinary
Frequency not reported: Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention
