Hycofenix

Last reviewed on RxList: 7/13/2018
Hycofenix Side Effects Center

Last reviewed on RxList 7/13/2018

Hycofenix (hydrocodone bitartrate, pseudoephedrine hydrochloride, and guaifenesin) oral solution is a combination an opioid antitussive, a nasal decongestant, and an expectorant indicated for the symptomatic relief of cough, nasal congestion, and to loosen mucus associated with the common cold. Common side effects of Hycofenix include:

  • dizziness,
  • headache,
  • drowsiness,
  • nausea,
  • diarrhea,
  • decreased blood pressure, and
  • hot flashes.

The dose of Hycofenix for adults and adolescents 18 years of age and older is 10 mL every 4 to 6 hours, not to exceed 4 doses (40 mL) in 24 hours. Hycofenix may interact with other opioids, antihistamines, antipsychotics, anti-anxiety agents, other CNS depressants (including alcohol), MAO inhibitors, tricyclic antidepressants, or anticholinergic drugs. Tell your doctor all medications and supplements you use. During pregnancy, Hycofenix should be used only if prescribed. Hydrocodone and pseudoephedrine pass into breast milk. It is unknown if guaifenesin passes into breast milk. Because of the potential for serious reactions in nursing infants, consult your doctor before breastfeeding. Hydrocodone can produce drug dependence. Withdrawal symptoms may occur if you suddenly stop taking Hycofenix.

Our Hycofenix (hydrocodone bitartrate, pseudoephedrine hydrochloride, and guaifenesin) oral solution 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.

QUESTION

Which illness is known as a viral upper respiratory tract infection? See Answer
Hycofenix Consumer Information

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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Hycofenix (Hydrocodone Bitartrate, Pseudoephedrine Hydrochloride, and Guaifenesin Oral Solution)

SLIDESHOW

Cold and Flu: Finding Relief for Your Cough See Slideshow
Hycofenix Professional Information

SIDE EFFECTS

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]
  • Cardiovascular and central nervous system effects [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 postapproval use of hydrocodone, pseudoephedrine, 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 HYCOFENIX include: 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.

Other Reactions Include

Anaphylaxis: Anaphylaxis has been reported with hydrocodone, one of the ingredients in HYCOFENIX.

Body as a whole: Coma, death, fatigue, falling injuries, lethargy, weakness, hyperthermia.

Cardiovascular: Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush, atrial fibrillation, myocardial infarction.

Central Nervous System: Ataxia, facial dyskinesia, insomnia, increased intracranial pressure, migraine, seizure, tremor.

Dermatologic: Flushing, hyperhidrosis, pruritus, rash. Cases of severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing products.

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 [see CLINICAL PHARMACOLOGY].

Gastrointestinal: Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi), dysgeusia, ischemic colitis.

Genitourinary: Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention.

Laboratory: Increases in serum amylase.

Musculoskeletal: Arthralgia, backache, muscle spasm, weakness.

Ophthalmic: Miosis (constricted pupils), visual disturbances, mydriasis (dilated pupils).

Psychiatric: Agitation, anxiety, confusion, fear, dysphoria, depression, hyperactivity, confusion, hallucinations, hyperexcitability.

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 Hycofenix (Hydrocodone Bitartrate, Pseudoephedrine Hydrochloride, and Guaifenesin Oral Solution)

© Hycofenix Patient Information is supplied by Cerner Multum, Inc. and Hycofenix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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