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Endacof-C Side Effects

Generic Name: chlorpheniramine / codeine

Note: This document contains side effect information about chlorpheniramine / codeine. Some of the dosage forms listed on this page may not apply to the brand name Endacof-C.

For the Consumer

Applies to chlorpheniramine / codeine: oral suspension extended release

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

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

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

References

1. "Product Information. Tuzistra XR (chlorpheniramine-codeine)." Vernalis Pharmaceuticals Inc, Morristown, NJ.

2. "Product Information. Zodryl AC Adult (chlorpheniramine-codeine)." codaDOSE Incorporated, Flowery Branch [Atlanta], GA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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