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Vicodin es

Generic Name: acetaminophen and hydrocodone (a SEET a MIN oh fen and hye droe KOE done)
Brand Names: Hycet, Lorcet, Lortab 10/325, Lortab 5/325, Lortab 7.5/325, Lortab Elixir, Norco, Verdrocet, Vicodin, Xodol
Vicodin (acetaminophen and hydrocodone) is used to relieve moderate to severe pain. Includes Vicodin side effects, interactions and indications.
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Drug Information:
Vicodin contains a combination of Acetaminophen and hydrocodone. Hydrocodone is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone. Vicodin tablets are used for the relief of moderate to moderately severe pain. Vicodin may also be used for purposes not listed in this medication guide. Hydrocodone can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Narcotic pain medicine may be habit-forming, even at regular doses. Never share Vicodin with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Learn more

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Vicodin es Side Effects

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 Vicodin.

For the Consumer

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.

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
  • dark urine
  • decrease in the frequency of urination
  • decrease in urine volume
  • difficult or troubled breathing
  • difficulty in passing urine (dribbling)
  • difficulty with swallowing
  • fast heartbeat
  • fever
  • fever with or without chills
  • general body swelling
  • general feeling of tiredness or weakness
  • headache
  • hoarseness
  • irregular, fast or slow, or shallow breathing
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • nausea
  • 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
  • vomiting
  • 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
  • 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 feeling
  • sleepiness

Incidence not known

  • Belching
  • changes in mood
  • difficulty having a bowel movement
  • 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.

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

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

Cardiovascular

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

Hepatic

Frequency not reported: Hepatic necrosis, hepatitis

Gastrointestinal

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

Dermatologic

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

Renal

Frequency not reported: Renal toxicity, renal tubular necrosis

Hematologic

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

Hypersensitivity

Frequency not reported: Allergic reactions, anaphylaxis

Respiratory

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

Metabolic

Frequency not reported: Hypoglycemic coma

Genitourinary

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

Endocrine

Opioids:

Frequency not reported: Androgen deficiency, adrenal insufficiency

Other

Frequency not reported: Hearing impairment or permanent loss

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

Musculoskeletal

Frequency not reported: Skeletal muscle flaccidity

Psychiatric

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

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Vicodin Es (www.drugs.com/vicodin.html).