Apadaz Side Effects
Generic Name: acetaminophen / benzhydrocodone
Note: This document contains side effect information about acetaminophen / benzhydrocodone. Some of the dosage forms listed on this page may not apply to the brand name Apadaz.
For the Consumer
Applies to acetaminophen/benzhydrocodone: oral tablet
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.
Side effects requiring immediate medical attention
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:
- Blurred vision
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- excess air or gas in the stomach or bowels
- feeling of warmth
- full or bloated feeling
- passing gas
- pressure in the stomach
- redness of the face, neck, arms, and occasionally, upper chest
- stomach pain
- swelling of the abdominal or stomach area
- tightness in the chest
- unusual tiredness or weakness
- chest discomfort
- false or unusual sense of well-being
- vomiting of blood
Incidence not known
- darkening of the skin
- difficulty swallowing
- fast heartbeat
- feeling sad or empty
- hives, itching, skin rash
- loss of appetite
- loss of interest or pleasure
- overactive reflexes
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- talking or acting with excitement you cannot control
- trembling or shaking
- trouble concentrating
- trouble sleeping
Side effects not requiring immediate medical attention
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:
- Lack or loss of strength
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- itching of the eye
- runny nose
- stuffy nose
For Healthcare Professionals
Applies to acetaminophen / benzhydrocodone: oral tablet
Frequency not reported: Rhinitis
Frequency not reported: Respiratory depression
Rhinitis has been reported in less than 1% of patients.
Common (1% to 10%): Pruritus
Rare (less than 0.1%): Serious skin reactions
Frequency not reported: Hepatotoxicity
Very common (10% or more): Nausea (21.5%), vomiting (13%), constipation (12%)
Frequency not reported: Diarrhea, gastroesophageal reflux disease, hematemesis
Diarrhea, gastroesophageal reflux disease, and hematemesis have been reported in less than 1% of patients.
Frequency not reported: Agitation, euphoric mood, nightmare
Agitation, euphoric mood, and nightmare have been reported in less than 1% of patients.
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.
Common (1% to 10%): Hypotension, hot flush
Frequency not reported: Chest discomfort
Chest discomfort has been reported in less than 1% of patients.
Frequency not reported: Eye pruritus
Eye pruritus has been reported in less than 1% of patients.
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.
Postmarketing reports: Anaphylaxis
Anaphylaxis has been reported with ingredients contained in this product.
1. "Product Information. Apadaz (acetaminophen-benzhydrocodone)." KemPharm, Inc, Coralville, IA.
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 Apadaz (acetaminophen / benzhydrocodone)
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: narcotic analgesic combinations
- FDA Alerts (2)
- FDA Approval History