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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 Lortab.
For the ConsumerApplies to acetaminophen / hydrocodone: oral elixir, oral solution, oral tablet
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
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / hydrocodone:
Symptoms of overdose
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
GeneralThe most commonly reported adverse reactions include light-headedness, dizziness, sedation, nausea and vomiting.
Nervous systemHydrocodone-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.
CardiovascularFrequency not reported: Bradycardia, cardiac arrest, circulatory collapse, hypotension
HepaticFrequency not reported: Hepatic necrosis, hepatitis
GastrointestinalFrequency not reported: Abdominal pain, constipation, gastric distress, heartburn, nausea, peptic ulcer, vomiting, occult blood loss
DermatologicFrequency not reported: Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions, cold and clammy skin, diaphoresis
RenalFrequency not reported: Renal toxicity, renal tubular necrosis
HematologicFrequency not reported: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia
HypersensitivityFrequency not reported: Allergic reactions, anaphylaxis
RespiratoryFrequency not reported: Acute airway obstruction, apnea, dose-related respiratory depression, shortness of breath
MetabolicFrequency not reported: Hypoglycemic coma
GenitourinaryFrequency not reported: Ureteral spasm, spasm of vesicle sphincters, urinary retention
EndocrineOpioids:
Frequency not reported: Androgen deficiency, adrenal insufficiency
OtherFrequency not reported: Hearing impairment or permanent loss
Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
MusculoskeletalFrequency not reported: Skeletal muscle flaccidity
PsychiatricFrequency not reported: Anxiety, euphoria, fear, mood changes, psychological dependence, dysphoria
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/3/2022.
Source: Drugs.com Lortab (www.drugs.com/lortab.html).
February 18, 2021
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