Pediatex-DM Side Effects

Generic name: carbinoxamine / dextromethorphan / pseudoephedrine

Note: This document provides detailed information about Pediatex-DM Side Effects associated with carbinoxamine / dextromethorphan / pseudoephedrine. Some dosage forms listed on this page may not apply specifically to the brand name Pediatex-DM.

Applies to carbinoxamine/dextromethorphan/pseudoephedrine: oral liquid, oral suspension extended release, oral syrup.

Important warnings This medicine can cause some serious health issues

Always ask a doctor before giving a cold or allergy medicine to a child, even if the medicine label provides dosing instructions for children. Death can occur from the misuse of cough and cold medicines in very young children.

Do not use carbinoxamine, dextromethorphan, and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take carbinoxamine, dextromethorphan, and pseudoephedrine before the MAO inhibitor has cleared from your body.

Carbinoxamine, dextromethorphan, and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of this medication.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.

Do not take this product for cough caused by smoking, asthma, or emphysema. Do not take this medicine if your cough produces a lot of mucus, unless your doctor has told you to.

Get emergency medical help if you have any of these signs of an allergic reaction: 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:

• feeling light-headed, fainting;

• urinating less than usual or not at all;

• wheezing, tightness in your chest;

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

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

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious side effects of carbinoxamine / dextromethorphan / pseudoephedrine may include:

• drowsiness, dizziness;

• lack of coordination;

• upset stomach;

• stuffy nose, chest congestion;

• sleep problems (insomnia);

• feeling restless or excited (especially in children);

• dry mouth or nose; or

• blurred vision.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For healthcare professionals

Applies to carbinoxamine / dextromethorphan / pseudoephedrine: oral liquid, oral suspension extended release, oral syrup.

General

General side effects have included pallor and weakness.^[Ref]

Gastrointestinal

Gastrointestinal side effects have included vomiting, diarrhea, dry mouth, nausea, anorexia, and heartburn.^[Ref]

Nervous system

Nervous system side effects have included sedation, dizziness, headache, nervousness, convulsions, central nervous system stimulation, insomnia, hallucinations, tremors and drowsiness.^[Ref]

Ocular

Ocular side effects have included diplopia.^[Ref]

Genitourinary

Genitourinary side effects have included polyuria and dysuria.^[Ref]

Respiratory

Respiratory side effects have included respiratory difficulty.^[Ref]

Cardiovascular

Cardiovascular side effects have included cardiac arrhythmias, increased heart rate or blood pressure.^[Ref]

Further information

Pediatex-DM side effects can vary depending on the individual. 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.

Medical Disclaimer