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Acetaminophen / benzhydrocodone Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 13, 2024.

Applies to acetaminophen / benzhydrocodone: oral tablet.

Warning

Oral route (Tablet)

Benzhydrocodone/acetaminophen exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing benzhydrocodone/acetaminophen, and monitor all patients regularly for the 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 with use of benzhydrocodone/acetaminophen. Monitor for respiratory depression, especially during initiation of benzhydrocodone/acetaminophen or following a dose increase.Accidental ingestion of even one dose of benzhydrocodone/acetaminophen, especially by children can result in a fatal overdose of hydrocodone.Prolonged use of benzhydrocodone/acetaminophen 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 prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.The concomitant use of benzhydrocodone/acetaminophen with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse reactions 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. Monitor patients receiving benzhydrocodone/acetaminophen and any CYP3A4 inhibitor or inducer.This product contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg/day, and often involve more than one acetaminophen-containing product.Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of benzhydrocodone/acetaminophen and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Serious side effects

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

Less common

Rare

Incidence not known

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

Symptoms of overdose

Other side effects

Some side effects of acetaminophen / benzhydrocodone 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

Less common

Rare

For Healthcare Professionals

Applies to acetaminophen / benzhydrocodone: oral tablet.

General

The most commonly reported adverse reactions have included nausea, somnolence, vomiting, constipation, pruritus, dizziness, and headache.[Ref]

Respiratory

Rhinitis has been reported in less than 1% of patients.

Frequency not reported: Rhinitis

Opioids:

Frequency not reported: Respiratory depression

Dermatologic

Common (1% to 10%): Pruritus

Acetaminophen:

Rare (less than 0.1%): Serious skin reactions

Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN) have been associated with acetaminophen use.

Hepatic

Acetaminophen:

Frequency not reported: Hepatotoxicity

Gastrointestinal

Very common (10% or more): Nausea (21.5%), vomiting (13%), constipation (12%)

Common (1% to 10%): Abdominal distension, abdominal pain, flatulence

Frequency not reported: Diarrhea, gastroesophageal reflux disease, hematemesis

Diarrhea, gastroesophageal reflux disease, and hematemesis have been reported in less than 1% of patients.

Psychiatric

Frequency not reported: Agitation, euphoric mood, nightmare

Agitation, euphoric mood, and nightmare have been reported in less than 1% of patients.

Nervous system

Very common (10% or more): Somnolence (18.5%)

Common (1% to 10%): Dizziness, headache, asthenia, presyncope, tremor

Frequency not reported: Syncope, hypoesthesia

Postmarketing reports: Serotonin syndrome

Syncope and hypoesthesia have been reported in less than 1% of patients. Cases of serotonin syndrome have been reported during concomitant use of opioids with serotonergic drugs.

Cardiovascular

Common (1% to 10%): Hypotension, hot flush

Frequency not reported: Chest discomfort

Chest discomfort has been reported in less than 1% of patients.

Ocular

Frequency not reported: Eye pruritus

Eye pruritus has been reported in less than 1% of patients.

Endocrine

Opioids:

Postmarketing reports: Adrenal insufficiency, androgen deficiency

Cases of adrenal insufficiency and androgen deficiency have been reported with opioid use, more often following greater chronic use.

Hypersensitivity

Postmarketing reports: Anaphylaxis

Anaphylaxis has been reported with ingredients contained in this product.

References

1. Product Information. Apadaz (acetaminophen-benzhydrocodone). KemPharm, Inc. 2018.

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.

Medical Disclaimer