Theraflu (pseudoephedrine) Daytime Severe Cold Side Effects

Generic name: acetaminophen / dextromethorphan / pseudoephedrine

Note: This document contains side effect information about acetaminophen / dextromethorphan / pseudoephedrine. Some of the dosage forms listed on this page may not apply to the brand name Theraflu (pseudoephedrine) Daytime Severe Cold.

Some side effects of Theraflu (pseudoephedrine) Daytime Severe Cold 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 acetaminophen / dextromethorphan / pseudoephedrine: oral capsule, oral liquid, oral powder for reconstitution, oral syrup, oral tablet, oral tablet chewable

Get emergency medical help if you have any of these signs of an allergic reaction while taking acetaminophen / dextromethorphan / pseudoephedrine: 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:

• chest pain, fast, slow, or uneven heart rate;

• severe dizziness, feeling like you might pass out;

• mood changes, confusion, hallucinations;

• tremor, seizure (convulsions);

• fever;

• urinating less than usual or not at all;

• nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

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

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

• dizziness, weakness;

• mild headache;

• mild nausea, diarrhea, upset stomach;

• dry mouth, nose, or throat;

• feeling nervous, restless, irritable, or anxious; or

• sleep problems (insomnia).

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 acetaminophen / dextromethorphan / pseudoephedrine: oral capsule, oral liquid, oral powder for reconstitution, oral syrup, oral tablet, oral tablet chewable

Cardiovascular

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

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.

One report evaluated the effect with 60 mg of pseudoephedrine on individuals in a hyperbaric chamber at 1 atmosphere (simulated scuba dive to 66 feet of sea water). Pseudoephedrine and depth (simulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.

Nervous system

Nervous system side effects of dextromethorphan have included drowsiness and dizziness. Other side effects such as excitation, mental confusion, and opioid like respiratory depression have been rare and occurred at higher dosages. In some cases of abuse, patients experienced euphoria, hyperactivity, mania, and auditory and visual hallucinations.

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

Gastrointestinal

Gastrointestinal side effects of dextromethorphan have included upset stomach.

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.

Hypersensitivity

Hypersensitivity side effects of dextromethorphan have included rare reports of fixed-drug eruptions.

Hypersensitivity side effects of pseudoephedrine have included fixed drug eruptions.

Hepatic

Hepatic side effects of acetaminophen have included severe and sometimes fatal dose dependent hepatitis in alcoholic patients. Hepatotoxicity has been increased during fasting.

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