Pancof HC Side Effects

Generic name: hydrocodone / pseudoephedrine

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

Some side effects of Pancof HC 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 hydrocodone / pseudoephedrine: oral liquid, oral solution, oral syrup, oral tablet

Along with its needed effects, 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 hydrocodone / pseudoephedrine:

• Blurred vision
• confusion
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, slow, or irregular heartbeat
• sweating
• unusual tiredness or weakness

• Abdominal or stomach cramps or pain
• bloating
• bulging soft spot on the head of an infant
• change in the ability to see colors, especially blue or yellow
• convulsions
• decrease in the frequency of urination
• decrease in urine volume
• diarrhea
• difficult or painful urination
• difficult or troubled breathing
• difficulty having a bowel movement (stool)
• difficulty in passing urine (dribbling)
• drowsiness
• frequent urge to urinate
• headache
• irregular, fast or slow, or shallow breathing
• loss of appetite
• nervousness
• pale or blue lips, fingernails, or skin
• pounding in the ears
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• sleeplessness
• trembling or shaking of the hands or feet
• trouble with sleeping
• unable to sleep
• vomiting

Some side effects of 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:

• Fear
• mood changes
• nausea
• relaxed and calm
• sleepiness
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

• Itching skin
• skin rash
• weakness

For Healthcare Professionals

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

Nervous system

Opioids may result in psychotic symptoms in some patients.

Nervous system side effects of hydrocodone have included mental and respiratory depression, stupor, delirium, somnolence, and dysphoria. Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.

Other

Other side effects of hydrocodone have included withdrawal symptoms, such as agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting and sweating, after either abrupt cessation or fast tapering of narcotic analgesics.

Gastrointestinal

Gastrointestinal side effects of hydrocodone have included nausea, vomiting, constipation, and dry mouth. 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.

Cardiovascular

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.

Genitourinary

Genitourinary side effects of hydrocodone have included ureteral spasm, spasm of vesicle sphincters, and urinary retention.

Dermatologic

Dermatologic side effects of hydrocodone have included rash.

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