Chlorpheniramine / dihydrocodeine / pseudoephedrine Side Effects

Some side effects of chlorpheniramine / dihydrocodeine / pseudoephedrine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to chlorpheniramine / dihydrocodeine / pseudoephedrine: oral syrup

Get emergency medical help if you have any of these signs of an allergic reaction while taking chlorpheniramine / dihydrocodeine / pseudoephedrine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeats;

• weak or shallow breathing, slow heartbeat;

• severe dizziness, fainting, anxiety, restless feeling, nervousness, or tremor;

• confusion, hallucinations, unusual thoughts or behavior;

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

• urinating less than usual or not at all; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects of chlorpheniramine / dihydrocodeine / pseudoephedrine may include:

• blurred vision;

• dry mouth;

• nausea, vomiting, stomach pain, constipation, mild loss of appetite;

• mild dizziness, drowsiness;

• problems with memory or concentration;

• ringing in your ears;

• warmth, redness, or tingling under your skin;

• feeling restless or excited (especially in children);

• sleep problems (insomnia); or

• skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to chlorpheniramine / dihydrocodeine / pseudoephedrine: oral syrup

General

General side effects including light-headedness, dizziness, drowsiness, headache, fatigue, and sedation have been among the most frequently reported with opioid use. Confusion, abdominal pain, lassitude, giddiness, increased irritability or excitement (especially in children) have been reported. Hallucinations, severe narcosis, and vivid dreams have been reported rarely.

Gastrointestinal

Gastrointestinal side effects of chlorpheniramine have included dry mouth and constipation in up to one-third of treated patients.

Gastrointestinal side effects including nausea, vomiting, and constipation have been among the most frequently reported with opioid use. Diarrhea, dry mouth, indigestion, anorexia, spasm of biliary tract have been reported.

Gastrointestinal side effects of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat have occurred in up to 15% of patients.

Nervous system

Nervous system side effects of chlorpheniramine have included drowsiness in 75% or more of treated patients. Dyskinesias have rarely been reported following chronic use of chlorpheniramine.

Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.

Nearly all patients treated with chlorpheniramine experience drowsiness. This drowsiness may subside in some patients with extended use.

Few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of chlorpheniramine extended over a period of 3 to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms.

Dermatologic

Dermatologic side effects including sweating, pruritus, and skin reactions have been among the most frequently reported with opioid use. Flushing has been reported.

Other

Other side effects of dihydrocodeine have included psychological dependence, physical dependence, and tolerance have been reported to develop upon repeated administration.

Symptoms of dihydrocodeine withdrawal consist of irritability, restlessness, insomnia, diaphoresis, anxiety, and palpitations.

Renal

Renal side effects including granulomatous interstitial nephritis and acute renal failure have been reported rarely during dihydrocodeine administration.

Cardiovascular

Cardiovascular side effects of chlorpheniramine have included hypotension, tachycardia, and palpitations.

Cardiovascular side effects of pseudoephedrine have included tachycardia. Some patients have developed hypertension and/or arrhythmias.

Respiratory

Respiratory side effects including respiratory depression have been reported.

Ocular

Ocular side effects including miosis and blurred vision have been reported.

Genitourinary

Genitourinary side effects including urinary retention have been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylactoid reactions have been reported rarely.

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