Codeine / phenylephrine Side Effects

Some side effects of codeine / phenylephrine 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 codeine / phenylephrine: oral liquid

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• fast or pounding heartbeat;

• feeling like you might pass out;

• chest tightness or congestion;

• easy bruising or bleeding, unusual weakness;

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

• seizure (convulsions); or

• painful or difficult urination.

Less serious side effects of codeine / phenylephrine may include:

• dizziness, drowsiness, headache;

• dry mouth, nose, or throat;

• nausea, vomiting, diarrhea, constipation;

• increased sweating or urination;

• feeling excited or restless;

• sleep problems (insomnia);

• blurred vision, dry eyes;

• ringing in your ears; or

• mild 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 codeine / phenylephrine: oral liquid

Nervous system

Nervous system side effects have included sedation, dizziness, sleepiness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, vertigo, hysteria, neuritis, tinnitus, acute labyrinthitis, and convulsions.

Ocular

Ocular side effects have included blurred vision and diplopia.

Gastrointestinal

Gastrointestinal side effects have included epigastric distress, anorexia, nausea, vomiting, diarrhea, and constipation.

Genitourinary

Genitourinary side effects have included urinary frequency, difficult urination, urinary retention, and early menses.

Respiratory

Respiratory side effects have included thickening of bronchial secretions, tightness of chest, wheezing, dryness of mouth, nose and throat, and nasal stuffiness.

Dermatologic

Dermatologic side effects have included urticaria, drug rash, photosensitivity, and pruritis.

Hypersensitivity

Hypersensitivity side effects have included anaphylactic shock.

Cardiovascular

Cardiovascular side effects have included hypotension, palpitations, tachycardia, and extra systoles.

Hematologic

Hematologic side effects have included hemolytic anemia, thrombocytopenia, and agranulocytosis.

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