Guaifenesin / Hydrocodone / Pseudoephedrine Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 2, 2024.

Applies to guaifenesin / hydrocodone / pseudoephedrine: oral liquid.

Important warnings This medicine can cause some serious health issues

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Stop using this medicine and call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing;

• confusion, severe weakness or drowsiness;

• tremors, severe restlessness;

• a seizure;

• irregular heartbeats;

• severe headache, blurred vision, pounding in your neck or ears;

• a light-headed feeling, like you might pass out;

• severe constipation, stomach pain; or

• adrenal gland problems--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common side effects may include:

• dizziness, drowsiness;

• headache;

• sleep problems (insomnia);

• nausea; or

• low blood pressure.

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 guaifenesin/hydrocodone/pseudoephedrine: oral liquid, oral tablet.

General adverse events

The most common adverse events were sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, tachycardia, arrhythmias including premature ventricular contractions, CNS stimulation including anxiety, restlessness, nervousness, tremor, and irritability.^[Ref]

Respiratory

• Frequency not reported: Bronchitis, cough, dyspnea, nasal congestion, nasopharyngitis, respiratory depression including fatal respiratory depression, sinusitis, upper respiratory tract infection

Cardiovascular

• Frequency not reported: Increased blood pressure, decreased blood pressure, tachycardia, chest pain, orthostatic hypotension, palpitations, syncope, prolonged QT interval, hot flush, atrial fibrillation, myocardial infarction, arrhythmias including premature ventricular contractions, flushing

Psychiatric

• Frequency not reported: Confusion, anxiety, dysphoria, agitation, addiction, abuse, misuse, fear, depression, hyperactivity, ataxia, hallucinations, hyperexcitability, opioid withdrawal syndrome, drug abuse, drug dependence

Nervous system

• Frequency not reported: Coma, ataxia, somnolence, facial dyskinesia, tremor, insomnia, migraine, increased intracranial pressure, seizure, dizziness, impaired mental and physical performance, serotonin syndrome

Serotonin syndrome has been reported with concomitant opioids and serotonergic drugs.

Gastrointestinal

• Frequency not reported: Abdominal pain, bowel obstruction, diarrhea, difficulty swallowing, GERD, indigestion, pancreatitis, paralytic ileus, dysgeusia, ischemic colitis, increase of serum amylase, dry mouth, biliary tract spasm (spasm of the sphincter of Oddi)

Dermatologic

• Frequency not reported: Hyperhidrosis, rash, pruritus, erythema, severe reactions such as acute generalized exanthematous pustulosis (AGEP)

Genitourinary

• Frequency not reported: Ureteral spasm, spasm of vesicle sphincters, urinary retention, urinary tract infection, hypogonadism, infertility

Endocrine

• Frequency not reported: Adrenal insufficiency, androgen deficiency

Adrenal insufficiency has been reported with opioid use, most often following greater than one month of use. Androgen deficiency has been reported with chronic opioid use.

Musculoskeletal

• Frequency not reported: Arthralgia, backache, muscle spasm

Ocular

• Frequency not reported: Miosis, visual disturbances

Metabolic

• Frequency not reported: Decreased appetite

Further information

Guaifenesin/hydrocodone/pseudoephedrine 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