Medical Editor: John P. Cunha, DO, FACOEP
Xtrelus (hydrocodone bitartrate and guaifenesin) is a combination of an opioid agonist and an expectorant, indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older. Common side effects of Xtrelus include:
- xsedation (drowsiness, mental clouding, lethargy),
- impaired mental and physical performance,
- dry mouth,
- vomiting, and
The dose of Xtrelus for adults 18 years of age and older is one tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours. Xtrelus may interact with serotonergic drugs, monoamine oxidase inhibitors (MAOIs), muscle relaxants, diuretics, anticholinergics, macrolide antibiotics, azole-antifungals, protease inhibitors, benzodiazepines or other CNS depressants (including alcohol, other sedatives/hypnotics, drugs for anxiety, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, rifampin, carbamazepine, or phenytoin. Tell your doctor all medications and supplements you use. Xtrelus is not recommended for use during pregnancy; it may harm a fetus. Breastfeeding is not recommended while using Xtrelus. Withdrawal symptoms may occur if you suddenly stop taking Xtrelus.
Our Xtrelus (hydrocodone bitartrate and guaifenesin) Tablets, for Oral Administration Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are described, or described in greater detail, in other sections:
- Addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS, Drug Abuse And Dependence]
- Life-threatening respiratory depression [see WARNINGS AND PRECAUTIONS, OVERDOSAGE]
- Accidental overdose and death due to medication errors [see WARNINGS AND PRECAUTIONS]
- Decreased mental alertness with impaired mental and/or physical abilities [see WARNINGS AND PRECAUTIONS]
- Interactions with benzodiazepines and other CNS depressants [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS]
- Paralytic ileus, gastrointestinal adverse reactions [see WARNINGS AND PRECAUTIONS]
- Increased intracranial pressure [see WARNINGS AND PRECAUTIONS]
- Obscured clinical course in patients with head injuries [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Severe hypotension [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Adrenal insufficiency [see WARNINGS AND PRECAUTIONS]
The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of hydrocodone and/or guaifenesin. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most common adverse reactions to Xtrelus include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation.
Other reactions include
Anaphylaxis: Anaphylaxis has been reported with hydrocodone, one of the ingredients in Xtrelus.
Body as a whole: Coma, death, fatigue, falling injuries, lethargy.
Cardiovascular: Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush.
Central Nervous System: Facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tremor.
Dermatologic: Flushing, hyperhidrosis, pruritus, rash.
Endocrine/Metabolic: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Cases of androgen deficiency have occurred with chronic use of opioids.
Gastrointestinal: Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, dry mouth, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi).
Genitourinary: Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention.
Laboratory: Increases in serum amylase.
Musculoskeletal: Arthralgia, backache, muscle spasm.
Ophthalmic: Miosis (constricted pupils), visual disturbances.
Psychiatric: Agitation, anxiety, confusion, fear, dysphoria, depression.
Reproductive: Hypogonadism, infertility.
Respiratory: Bronchitis, cough, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, upper respiratory tract infection.
Other: Drug abuse, drug dependence, opioid withdrawal syndrome.
Read the entire FDA prescribing information for Xtrelus (Hydrocodone Bitartrate and Guaifenesin Tablets)