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Hyphed Side Effects

Generic Name: chlorpheniramine / hydrocodone / pseudoephedrine

Note: This document contains side effect information about chlorpheniramine / hydrocodone / pseudoephedrine. Some of the dosage forms listed on this page may not apply to the brand name Hyphed.

For the Consumer

Applies to chlorpheniramine/hydrocodone/pseudoephedrine: oral solution

Warning

Oral route (Solution)

Warning: Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; medication errors; cytochrome P450 3A4 interaction; concomitant use with benzodiazepines or other CNS depressants; interaction with alcohol; neonatal opioid withdrawal syndromeAddiction, Abuse, and MisuseHydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient’s risk prior to prescribing hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride, prescribe hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride or when used in patients at higher risk.Accidental IngestionAccidental ingestion of even one dose of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride, especially by children, can result in a fatal overdose of hydrocodone.Risk of Medication ErrorsEnsure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride.Cytochrome P450 3A4 InteractionThe concomitant use of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride in patients taking a CYP3A4 inhibitor or inducer.Risk from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride in patients taking benzodiazepines, other CNS depressants, or alcohol.Interaction with AlcoholInstruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride. The co-ingestion of alcohol with hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride may result in increased plasma levels and a potentially fatal overdose of hydrocodone.Neonatal Opioid Withdrawal SyndromeHydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride is not recommended for use in pregnant women. Prolonged use of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Along with its needed effects, chlorpheniramine / hydrocodone / pseudoephedrine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking chlorpheniramine / hydrocodone / pseudoephedrine:

More Common

  • Fainting
  • lightheadedness
  • shakiness in the legs, arms, hands, or feet
  • trembling or shaking of the hands or feet
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence Not Known

  • Bloating
  • blurred vision
  • bulging soft spot on the head of an infant
  • change in the ability to see colors, especially blue or yellow
  • confusion
  • constipation
  • decrease in the frequency of urination
  • decrease in the urine volume
  • diarrhea
  • difficult or troubled breathing
  • difficulty in passing urine (dribbling)
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • fast, slow, or irregular heartbeat
  • headache
  • hives or welts, itching, skin rash
  • irregular, fast or slow, or shallow breathing
  • loss of appetite
  • loss of consciousness
  • nervousness
  • painful urination
  • pale or blue lips, fingernails, or skin
  • pounding in the ears
  • seizures
  • sore throat
  • spasm of the throat
  • stomach cramps or pain
  • sweating
  • tightness of the chest
  • vomiting
  • yellow eyes or skin

Some side effects of chlorpheniramine / hydrocodone / pseudoephedrine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Deep or fast breathing with dizziness
  • disturbed color perception
  • double vision
  • dry mouth
  • false or unusual sense of well-being
  • fear or nervousness
  • halos around lights
  • nausea
  • night blindness
  • numbness of the feet, hands, and around the mouth
  • overbright appearance of lights
  • relaxed and calm feeling
  • restlessness
  • sleepiness or unusual drowsiness
  • trouble sleeping
  • tunnel vision

Incidence Not Known

  • Belching
  • bigger, dilated, or enlarged pupils (black part of the eye)
  • bloating
  • change in color vision
  • chills
  • cold sweats
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cool, pale skin
  • darkened urine
  • depression
  • difficulty seeing at night
  • feeling of constant movement of self or surroundings
  • fever
  • flushing or redness of the skin
  • full feeling
  • hearing loss
  • heartburn
  • increased appetite
  • increased hunger
  • increased in sexual ability, desire, drive, or performance
  • increased interest in sexual intercourse
  • increased sensitivity of the eyes to sunlight
  • increased sweating
  • indigestion
  • nightmares
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pressure in the stomach
  • sensation of spinning
  • slurred speech
  • stomach discomfort or upset
  • sugar in the urine
  • swelling of the abdominal or stomach area
  • swelling of the breasts or breast soreness in both females and males
  • unusually warm skin
  • watering of the eyes

For Healthcare Professionals

Applies to chlorpheniramine / hydrocodone / pseudoephedrine: oral capsule, oral liquid, oral suspension extended release, oral syrup, oral tablet

General

The more commonly reported adverse effects have included sedation (somnolence, mental clouding, lethargy), lightheadedness, headache, dry mouth, restlessness, 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, thickening of bronchial secretions, tightness of chest wheezing, dry nose, dry throat

Gastrointestinal

Frequency not reported: Abdominal pain, acute pancreatitis, 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)

Nervous system

Frequency not reported: Coma, somnolence, facial dyskinesia, tremor, insomnia, migraine, increased intracranial pressure, seizure, dizziness, decreased mental alertness with impaired mental and/or physical abilities, serotonin syndrome, tinnitus

Serotonin syndrome has been reported with concomitant opioids and serotonergic drugs

Psychiatric

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

Genitourinary

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

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

Other

Frequency not reported: Vertigo, peripheral edema, death, falling injuries, weakness, hyperthermia, ataxia, accidental overdose, neonatal opioid withdrawal syndrome

Hypersensitivity

Frequency not reported: Anaphylaxis

Dermatologic

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

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.

Ocular

Frequency not reported: Blurred vision, mydriasis, miosis, visual disturbances, diplopia

Metabolic

Frequency not reported: Decreased appetite

Hematologic

Frequency not reported: Agranulocytosis, aplastic anemia, thrombocytopenia

Musculoskeletal

Frequency not reported: Arthralgia, backache, muscle spasm

References

1. "Product Information. Zutripro (chlorpheniramine/hydrocodone/PSE)." Hawthorn Pharmaceuticals, Madison, MS.

Further information

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.

More about Hyphed (chlorpheniramine / hydrocodone / pseudoephedrine)

Consumer resources

Other brands: Zutripro, Hydron PCS, Notuss-Forte

Professional resources

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