Acetaminophen / dextromethorphan / pseudoephedrine Side Effects
Some side effects of acetaminophen / dextromethorphan / 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 acetaminophen / dextromethorphan / pseudoephedrine: capsules, chewable tablets, drops, liquid, powder packet, syrup, tablets
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking acetaminophen / dextromethorphan / pseudoephedrine:
Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.
For Healthcare Professionals
Applies to acetaminophen / dextromethorphan / pseudoephedrine: oral capsule, oral liquid, oral powder for reconstitution, oral syrup, oral tablet, oral tablet chewable
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 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 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 side effects of dextromethorphan have included rare reports of fixed-drug eruptions.
Hypersensitivity side effects of pseudoephedrine have included fixed drug eruptions.
Hepatic side effects of acetaminophen have included severe and sometimes fatal dose dependent hepatitis in alcoholic patients. Hepatotoxicity has been increased during fasting.
Dermatologic side effects associated with acetaminophen includes the risk of rare but potentially fatal serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).
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