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Apadaz Side Effects

Generic name: acetaminophen / benzhydrocodone

Medically reviewed by Drugs.com. Last updated on Dec 4, 2024.

Note: This document provides detailed information about Apadaz Side Effects associated with acetaminophen / benzhydrocodone. Some dosage forms listed on this page may not apply specifically to the brand name Apadaz.

Applies to acetaminophen / benzhydrocodone: oral tablet.

Important warnings This medicine can cause some serious health issues

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.

Precautions

It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone and other medicines to treat an overdose.Signs of an overdose include: dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

For nursing mothers taking this medicine:

This medicine may cause serious skin reactions (eg, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis). Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a cough, dizziness, fast heartbeat, hives, rash, itching, puffiness or swelling of the eyelids, or around the eyes, face, lips, or tongue, tightness in the chest, trouble breathing or swallowing, or unusual tiredness or weakness while you are using this medicine.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, confused, or disoriented. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink 3 or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of Apadaz

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 side effects

  • constipation

Less common side effects

  • lack or loss of strength

Rare side effects

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • diarrhea
  • itching of the eye
  • nightmare
  • runny nose
  • sneezing
  • stuffy nose

Serious side effects of Apadaz

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 side effects

  • blurred vision
  • confusion
  • 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
  • shakiness in the legs, arms, hands, or feet
  • stomach pain
  • sweating
  • swelling of the stomach area
  • tightness in the chest
  • trembling or shaking of the hands or feet
  • unusual tiredness or weakness

Rare side effects

  • agitation
  • chest discomfort
  • fainting
  • false or unusual sense of well-being
  • heartburn
  • vomiting
  • vomiting of blood

Incidence not known

  • cough
  • darkening of the skin
  • diarrhea
  • difficulty swallowing
  • discouragement
  • dizziness
  • fast heartbeat
  • feeling sad or empty
  • fever
  • hives, itching, skin rash
  • irritability
  • loss of appetite
  • loss of interest or pleasure
  • nausea
  • overactive reflexes
  • poor coordination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • restlessness
  • shivering
  • talking or acting with excitement you cannot control
  • trembling or shaking
  • trouble concentrating
  • trouble sleeping
  • twitching

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

Symptoms of overdose

For healthcare professionals

Applies to acetaminophen / benzhydrocodone: oral tablet.

General adverse events

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

Respiratory

Opioids:

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

Dermatologic

Acetaminophen:

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:

Gastrointestinal

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

Psychiatric

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

Nervous system

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

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

Ocular

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

Endocrine

Opioids:

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

Hypersensitivity

Anaphylaxis has been reported with ingredients contained in this product.

See also:

References

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

Frequently asked questions

Further information

Apadaz side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.