Note: This document contains side effect information about acetaminophen / hydrocodone. Some dosage forms listed on this page may not apply to the brand name Xodol.
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.
Serious side effects of Xodol
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
- Agitation
- back, leg, or stomach pains
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- blood in vomit
- bluish lips or skin
- chills
- choking
- confusion
- cough
- dark urine
- darkening of the skin
- decrease in the frequency of urination
- decrease in urine volume
- diarrhea
- difficult or trouble breathing
- difficulty in passing urine (dribbling)
- difficulty with swallowing
- fainting
- 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
- joint or muscle pain
- light-colored stools
- loss of appetite
- lower back or side pain
- mental depression
- nausea
- nosebleeds
- not breathing
- overactive reflexes
- painful or difficult urination
- pale or blue lips, fingernails, or skin
- pinpoint red spots on the skin
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red irritated eyes
- red skin lesions, often with a purple center
- restlessness
- severe or continuing stomach pain
- shivering
- skin rash, hives, or itching
- sore throat
- sore tongue
- sores, ulcers, or white spots on the lips or in the mouth
- sweating
- talking or acting with excitement you cannot control
- tightness in the chest
- trembling or shaking
- twitching
- 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
- coughing that sometimes produces a pink frothy sputum
- decreased awareness or responsiveness
- difficult or trouble breathing
- extreme drowsiness
- general feeling of discomfort or illness
- increased sweating
- irregular, fast or slow, or shallow breathing
- irregular heartbeat
- lightheadedness, dizziness, or fainting
- loss of consciousness
- no blood pressure or pulse
- no muscle tone or movement
- not breathing
- pale or blue lips, fingernails, or skin
- severe sleepiness
- slow or irregular heartbeat
- stopping of heart
- sudden decrease in the amount of urine
- swelling in the legs and ankles
- unpleasant breath odor
Other side effects of Xodol
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.[Ref]
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[Ref]
Cases of serotonin syndrome have been reported during concomitant use of opioids with serotonergic drugs.[Ref]
Cardiovascular
Frequency not reported: Bradycardia, cardiac arrest, circulatory collapse, hypotension
Hepatic
Frequency not reported: Hepatic necrosis, hepatitis[Ref]
Gastrointestinal
Frequency not reported: Abdominal pain, constipation, gastric distress, heartburn, nausea, peptic ulcer, vomiting, occult blood loss[Ref]
Dermatologic
Frequency not reported: Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions, cold and clammy skin, diaphoresis[Ref]
Renal
Frequency not reported: Renal toxicity, renal tubular necrosis[Ref]
Hematologic
Frequency not reported: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia[Ref]
Hypersensitivity
Frequency not reported: Allergic reactions, anaphylaxis[Ref]
Respiratory
Frequency not reported: Acute airway obstruction, apnea, dose-related respiratory depression, shortness of breath[Ref]
Metabolic
Frequency not reported: Hypoglycemic coma
Genitourinary
Frequency not reported: Ureteral spasm, spasm of vesicle sphincters, urinary retention[Ref]
Endocrine
Opioids:
Frequency not reported: Androgen deficiency, adrenal insufficiency
Other
Frequency not reported: Hearing impairment or permanent loss[Ref]
Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.[Ref]
Musculoskeletal
Frequency not reported: Skeletal muscle flaccidity
Psychiatric
Frequency not reported: Anxiety, euphoria, fear, mood changes, psychological dependence, dysphoria
