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Codar D Side Effects

Generic Name: codeine / pseudoephedrine

Note: This document contains side effect information about codeine / pseudoephedrine. Some of the dosage forms listed on this page may not apply to the brand name Codar D.

For the Consumer

Applies to codeine / pseudoephedrine: oral liquid

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Chest pain or pressure or a fast heartbeat.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Noisy breathing.
  • Feeling very sleepy.
  • Feeling confused.
  • A heartbeat that does not feel normal.
  • Hallucinations (seeing or hearing things that are not there).
  • Mood changes.
  • Seizures.
  • Very bad belly pain.
  • Very bad headache.
  • Trouble passing urine.
  • Shakiness.
  • Change in eyesight.
  • Very upset stomach or throwing up.
  • Very hard stools (constipation).
  • Feeling very tired or weak.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling nervous and excitable.
  • Not able to sleep.
  • Hard stools (constipation).
  • Feeling sleepy.
  • Upset stomach or throwing up.
  • Sweating a lot.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to codeine/pseudoephedrine: oral capsule, oral liquid, oral syrup

General

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

Respiratory

Codeine:

Frequency not reported: Respiratory depression[Ref]

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

Pseudoephedrine:

Frequency not reported: Restlessness, dizziness, weakness, headache, drowsiness, tremor[Ref]

Gastrointestinal

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

Codeine

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

Pseudoephedrine:

Frequency not reported: Nausea, vomiting, dry mouth[Ref]

Psychiatric

Codeine

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

Pseudoephedrine:

Frequency not reported: Hallucinations (particularly in children), anxiety, excitability, insomnia[Ref]

Cardiovascular

Codeine

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

Pseudoephedrine:

Frequency not reported: Tachycardia, palpitations, cardiac arrhythmias, hypertension, impaired circulation to the extremities[Ref]

Dermatologic

Codeine:

Frequency not reported: Rash

Pseudoephedrine:

Frequency not reported: Fixed drug eruption in the form of erythematous nodular patches, rash[Ref]

Genitourinary

Codeine

Frequency not reported: Oliguria, urinary retention, antidiuretic effect

Pseudoephedrine:

Frequency not reported: Urinary retention[Ref]

Hypersensitivity

Codeine

Frequency not reported: Pruritus, giant urticaria, angioneurotic edema, laryngeal edema[Ref]

Ocular

Codeine

Frequency not reported: Visual disturbances

Pseudoephedrine:

Frequency not reported: Angle-closure glaucoma[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

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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