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Hydrocet Side Effects

Generic name: acetaminophen / hydrocodone

Medically reviewed by Drugs.com. Last updated on Jun 30, 2023.

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

Applies to acetaminophen / hydrocodone: oral elixir, oral solution, oral tablet.

Warning

Oral route (Solution)

Hydrocodone bitartrate and acetaminophen oral solution has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors and conditions. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of hydrocodone bitartrate and acetaminophen oral solution, especially by children, can result in a fatal overdose of hydrocodone bitartrate and acetaminophen. Prolonged use of hydrocodone bitartrate and acetaminophen oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Monitor patients receiving hydrocodone bitartrate and acetaminophen oral solution and any CYP3A4 inhibitor or inducer for signs of respiratory depression or sedation. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death, most often with the use of acetaminophen at doses that exceed 4000 mg/day, and involving more than 1 acetaminophen-containing product. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.

Oral route (Tablet)

Hydrocodone bitartrate and acetaminophen has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors and conditions. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of hydrocodone bitartrate and acetaminophen, especially by children, can result in a fatal overdose of hydrocodone bitartrate and acetaminophen. Prolonged use of hydrocodone bitartrate and acetaminophen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Monitor patients receiving hydrocodone bitartrate and acetaminophen and any CYP3A4 inhibitor or inducer for signs of respiratory depression or sedation. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death, most often with the use of acetaminophen at doses that exceed 4000 mg/day, and involving more than 1 acetaminophen-containing product. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.

Serious side effects of Hydrocet

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

Incidence not known

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

Symptoms of overdose

Other side effects of Hydrocet

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

Incidence not known

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

2. Product Information. Norco (acetaminophen-hydrocodone). Allergan Inc. 2017.

3. Product Information. Lortab (acetaminophen-hydrocodone). Akorn Inc. 2017.

4. Product Information. Acetaminophen-Hydrocodone Bitartrate (acetaminophen-hydrocodone). Mikart Inc. 2017.

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

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

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

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. 1984;51:222-6.

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

10. Jackson CH, MacDonald NC, Cornett JW. Acetaminophen: a practical pharmacologic overview. Can Med Assoc J. 1984;131:25-37.

11. Black M. Acetaminophen hepatotoxicity. Annu Rev Med. 1984;35:577-93.

12. 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. 1985;145:2019-23.

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

14. Minton NA, Henry JA, Frankel RJ. Fatal paracetamol poisoning in an epileptic. Hum Toxicol. 1988;7:33-4.

15. Keaton MR. Acute renal failure in an alcoholic during therapeutic acetaminophen ingestion. South Med J. 1988;81:1163-6.

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

17. Wong V, Daly M, Boon A, Heatley V. Paracetamol and acute biliary pain with cholestasis. Lancet. 1993;342:869.

18. Csete M, Sullivan JB. Vicodin-induced fulminant hepatic failure. Anesthesiology. 1993;79:857-60.

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

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

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

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

23. Shoenfeld Y, Shaklai M, Livni E, Pinkhas J. Thrombocytopenia from acetaminophen. N Engl J Med. 1980;303:47.

24. 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. 2007;109:3608-9.

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

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

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

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

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.