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Zyfrel Side Effects

Generic Name: acetaminophen / hydrocodone

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

For the Consumer

Applies to acetaminophen / hydrocodone: oral capsule, oral elixir, oral liquid, oral solution, oral syrup, oral tablet

Along with its needed effects, acetaminophen / hydrocodone 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 acetaminophen / hydrocodone:

More common
  • Dizziness
  • lightheadedness
Incidence not known
  • Back, leg, or stomach pains
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blood in vomit
  • bluish lips or skin
  • chills
  • choking
  • cough or hoarseness
  • dark urine
  • decrease in the frequency of urination
  • decrease in urine volume
  • difficult or troubled breathing
  • difficulty in passing urine (dribbling)
  • difficulty with breathing
  • difficulty with swallowing
  • fast heartbeat
  • fever
  • fever with or without chills
  • general body swelling
  • general feeling of tiredness or weakness
  • headache
  • irregular, fast or slow, or shallow breathing
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • nausea or vomiting
  • nosebleeds
  • not breathing
  • painful or difficult urination
  • pale or blue lips, fingernails, or skin
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • severe or continuing stomach pain
  • skin rash, hives, or itching
  • sore throat
  • sore tongue
  • sores, ulcers, or white spots on the lips or in the mouth
  • tightness in the chest
  • unable to speak
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / hydrocodone:

Symptoms of overdose
  • Bloody or cloudy urine
  • change in consciousness
  • chest pain or discomfort
  • cold and clammy skin
  • decreased awareness or responsiveness
  • extreme drowsiness
  • general feeling of discomfort or illness
  • increased sweating
  • irregular heartbeat
  • lightheadedness, dizziness, or fainting
  • loss of consciousness
  • no blood pressure or pulse
  • no muscle tone or movement
  • not breathing
  • severe sleepiness
  • slow or irregular heartbeat
  • stopping of heart
  • sudden decrease in the amount of urine
  • unconsciousness
  • unpleasant breath odor

Some side effects of acetaminophen / hydrocodone 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
  • Drowsiness
  • relaxed and calm
  • sleepiness
Incidence not known
  • Belching
  • changes in mood
  • difficulty having a bowel movement (stool)
  • fear or nervousness
  • feeling of indigestion
  • hearing loss
  • impaired hearing
  • pain in the chest below the breastbone
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

For Healthcare Professionals

Applies to acetaminophen / hydrocodone: oral capsule, oral elixir, oral liquid, oral solution, oral tablet

General

The most commonly reported adverse reactions include light-headedness, dizziness, sedation, nausea and vomiting.[Ref]

Nervous system

Hydrocodone-acetaminophen:
Frequency not reported: Dizziness, lightheadedness, mental and physical performance impairment, lethargy, sedation, somnolence progressing to stupor or coma

Opioids:
Frequency not reported: Serotonin syndrome[Ref]

Cases of serotonin syndrome have been reported during concomitant use of opioids with serotonergic drugs.[Ref]

Cardiovascular

Frequency not reported: Bradycardia, cardiac arrest, circulatory collapse, hypotension

Hepatic

Frequency not reported: Hepatic necrosis, hepatitis[Ref]

Gastrointestinal

Frequency not reported: Abdominal pain, constipation, gastric distress, heartburn, nausea, peptic ulcer, vomiting, occult blood loss[Ref]

Dermatologic

Frequency not reported: Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions, cold and clammy skin, diaphoresis[Ref]

Renal

Frequency not reported: Renal toxicity, renal tubular necrosis[Ref]

Hematologic

Frequency not reported: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia[Ref]

Hypersensitivity

Frequency not reported: Allergic reactions, anaphylaxis[Ref]

Respiratory

Frequency not reported: Acute airway obstruction, apnea, dose-related respiratory depression, shortness of breath[Ref]

Metabolic

Frequency not reported: Hypoglycemic coma

Genitourinary

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

Endocrine

Opioids:
Frequency not reported: Androgen deficiency, adrenal insufficiency

Other

Frequency not reported: Hearing impairment or permanent loss[Ref]

Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.[Ref]

Musculoskeletal

Frequency not reported: Skeletal muscle flaccidity

Psychiatric

Frequency not reported: Anxiety, euphoria, fear, mood changes, psychological dependence, dysphoria

References

1. "Product Information. Norco (acetaminophen-hydrocodone)." Allergan Inc, Irvine, CA.

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

3. "Product Information. Lortab (acetaminophen-hydrocodone)." Akorn Inc, Buffalo Grove, IL.

4. "Product Information. Acetaminophen-Hydrocodone Bitartrate (acetaminophen-hydrocodone)." Mikart Inc, Atlanta, GA.

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

6. 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

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. 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

9. Seeff LB, Cuccherini BA, Zimmerman HJ, Adler E, Benjamin SB "Acetaminophen hepatotoxicity in alcoholics." Ann Intern Med 104 (1986): 399-404

10. Minton NA, Henry JA, Frankel RJ "Fatal paracetamol poisoning in an epileptic." Hum Toxicol 7 (1988): 33-4

11. Csete M, Sullivan JB "Vicodin-induced fulminant hepatic failure." Anesthesiology 79 (1993): 857-60

12. Keaton MR "Acute renal failure in an alcoholic during therapeutic acetaminophen ingestion." South Med J 81 (1988): 1163-6

13. Shriner K, Goetz MB "Severe hepatotoxicity in a patient receiving both acetaminophen and zidovudine." Am J Med 93 (1992): 94-6

14. Black M "Acetaminophen hepatotoxicity." Annu Rev Med 35 (1984): 577-93

15. Kaysen GA, Pond SM, Roper MH, Menke DJ, Marrama MA "Combined hepatic and renal injury in alcoholics during therapeutic use of acetaminophen." Arch Intern Med 145 (1985): 2019-23

16. Jackson CH, MacDonald NC, Cornett JW "Acetaminophen: a practical pharmacologic overview." Can Med Assoc J 131 (1984): 25-37

17. O'Dell JR, Zetterman RK, Burnett DA "Centrilobular hepatic fibrosis following acetaminophen-induced hepatic necrosis in an alcoholic." JAMA 255 (1986): 2636-7

18. Wong V, Daly M, Boon A, Heatley V "Paracetamol and acute biliary pain with cholestasis." Lancet 342 (1993): 869

19. Thomas RH, Munro DD "Fixed drug eruption due to paracetamol." Br J Dermatol 115 (1986): 357-9

20. Guin JD, Haynie LS, Jackson D, Baker GF "Wandering fixed drug eruption: a mucocutaneous reaction to acetaminophen." J Am Acad Dermatol 17 (1987): 399-402

21. Segasothy M, Suleiman AB, Puvaneswary M, Rohana A "Paracetamol: a cause for analgesic nephropathy and end-stage renal disease." Nephron 50 (1988): 50-4

22. Gabriel R, Caldwell J, Hartley RB "Acute tubular necrosis, caused by therapeutic doses of paracetamol?" Clin Nephrol 18 (1982): 269-71

23. Bougie DW, Benito AI, Sanchez-Abarca LI, Torres R, Birenbaum J, Aster RH "Acute thrombocytopenia caused by sensitivity to the glucuronide conjugate of acetaminophen." Blood 109 (2007): 3608-9

24. Shoenfeld Y, Shaklai M, Livni E, Pinkhas J "Thrombocytopenia from acetaminophen." N Engl J Med 303 (1980): 47

25. Settipane RA, Stevenson DD "Cross sensitivity with acetaminophen in aspirin-sensitive subjects with asthma." J Allergy Clin Immunol 84 (1989): 26-33

26. Van Diem L, Grilliat JP "Anaphylactic shock induced by paracetamol." Eur J Clin Pharmacol 38 (1990): 389-90

27. Kondo K, Inoue Y, Hamada H, Yokoyama A, Kohno N, Hiwada K "Acetaminophen-induced eosinophilic pneumonia." Chest 104 (1993): 291-2

28. Cohen J, Tattersfield H, Lloyd D, Cantopher T "A request for a strong analgesic." Practitioner 234 (1990): 691-4

Some side effects of Zyfrel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

More about Zyfrel (acetaminophen / hydrocodone)

Consumer resources

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Professional resources

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Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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