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Histinex D 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 Histinex D.

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:

More common
  • 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
Incidence not known
  • 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
  • trembling or shaking of the hands or feet
  • trouble with sleeping
  • 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:

More common
  • Fear
  • mood changes
  • nausea
  • relaxed and calm
  • sleepiness
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Incidence not known

For Healthcare Professionals

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

General

The most commonly reported adverse effects have included, sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes, nervousness, sleeplessness, tremor, or arrhythmia.[Ref]

Respiratory

Frequency not reported: Dose-related respiratory depression including fatal respiratory depression

Psychiatric

Frequency not reported: Mental clouding, anxiety, fear, dysphoria, psychic dependence, mood changes, sleeplessness

Cardiovascular

Frequency not reported: Fast, slow heartbeat, hypertension, hypotension, orthostatic hypotension, palpitation, shock-like state, syncope, arrhythmia[Ref]

Nervous system

Frequency not reported: Sedation, drowsiness, lethargy, mental and physical impairment, dizziness, tremor[Ref]

Gastrointestinal

Frequency not reported: Nausea, vomiting, constipation[Ref]

Dermatologic

Frequency not reported: Skin rash, pruritus[Ref]

Genitourinary

Frequency not reported: Ureteral spasm, spasm of vesicle sphincters, urinary retention[Ref]

References

1. "Product Information. Rezira (hydrocodone-pseudoephedrine)." Hawthorn Pharmaceuticals, Madison, MS.

2. Rosen RA "Angina associated with pseudoephedrine ." Ann Emerg Med 10 (1981): 230-1

3. Wiener I, Tilkian AG, Palazzolo M "Coronary artery spasm and myocardial infarction in a patient with normal coronary arteries: temporal relationship to pseudoephedrine ingestion." Cathet Cardiovasc Diagn 20 (1990): 51-3

4. "Product Information. Histussin D (hydrocodone-pseudoephedrine)" Sanofi Winthrop Pharmaceuticals, New York, NY.

5. Mariani PJ "Pseudoephedrine-induced hypertensive emergency: treatment with labetalol." Am J Emerg Med 4 (1986): 141-2

6. Turturro MA, Paris PM, Yealy DM, Menegazzi JJ "Hydrocodone versus codeine in acute musculoskeletal pain." Ann Emerg Med 20 (1991): 1100-3

7. Morrow PL, Faris EC "Death associated with inadvertent hydrocodone overdose in a child with a respiratory tract infection." Am J Forensic Med Pathol 8 (1987): 60-3

8. Fricke J, Halladay SC, Bynum L, Francisco CA "Pain relief after dental impaction surgery using ketorolac, hydrocodone plus acetaminophen, or placebo." Clin Ther 15 (1993): 500-9

9. Sackner MA "Effects of hydrocodone bitartrate on breathing pattern of patients with chronic obstructive pulmonary disease and restrictive lung disease." Mt Sinai J Med 51 (1984): 222-6

10. Sorensen JL, Hargreaves WA, Weinberg JA "Heroin addict responses to six weeks of detoxification with LAAM." Drug Alcohol Depend 9 (1982): 79-87

11. Morrison AB "Toxicity and abuse of hydrocodone bitartrate." Can Med Assoc J 120 (1979): 1338

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 Histinex D (hydrocodone / pseudoephedrine)

Consumer resources

Other brands: Pancof HC, Rezira

Professional resources

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