Percocet 5 / 325
Name: Percocet 5 / 325
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For the Consumer
Applies to acetaminophen / oxycodone: oral capsule, oral solution, oral tablet, oral tablet extended release
Along with its needed effects, acetaminophen/oxycodone 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 / oxycodone:
More common- Abdominal or stomach pain
- black, tarry stools
- chills
- dark urine
- dizziness
- fever
- headache
- itching
- light-colored stools
- loss of appetite
- nausea
- rash
- unpleasant breath odor
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
- Cough or hoarseness
- fever with or without chills
- general feeling of tiredness or weakness
- lower back or side pain
- painful or difficult urination
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- unusual bleeding or bruising
- Back, leg, or stomach pains
- bleeding gums
- bloating
- blood in the urine or stools
- blue lips and fingernails
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- clay-colored stools
- cloudy urine
- clumsiness
- confusion
- constipation
- coughing that sometimes produces a pink frothy sputum
- decreased awareness or responsiveness
- decreased frequency or amount of urine
- difficult or labored breathing
- difficult or painful urination
- difficult, fast, noisy breathing, sometimes with wheezing
- difficulty in passing urine (dribbling)
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- dry mouth
- extremely shallow or slow breathing
- fainting
- fast or deep breathing
- fast, slow, irregular, pounding, or racing heartbeat
- feeling of warmth
- general body swelling
- increased sweating
- increased thirst
- indigestion
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness
- muscle aches
- muscle tremors
- muscle weakness
- nervousness
- noisy breathing
- nosebleeds
- numbness or tingling in the hands, feet, or lips
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid, deep or shallow breathing
- redness of the face, neck, arms, and occasionally, upper chest
- restlessness
- seizures
- severe constipation
- severe sleepiness
- severe vomiting
- skin blisters
- skin rash, hives, or welts
- sleepiness
- sore throat
- stomach cramps
- sunken eyes
- sweating
- swelling of the face, fingers, lower legs, or ankles
- thirst
- tightness in the chest
- tiredness
- vomiting
- weakness or heaviness of the legs
- weight gain
Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / oxycodone:
Symptoms of overdose- Bluish lips or skin
- change in consciousness
- cold, clammy skin
- extreme sleepiness
- general feeling of discomfort or illness
- loss of consciousness
- low blood pressure or pulse
- slow breathing
- unconsciousness
Some side effects of acetaminophen / oxycodone 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- Relaxed and calm feeling
- Acid or sour stomach
- agitation
- bad, unusual or unpleasant (after) taste
- belching
- change in taste
- cold sweats
- constricted, pinpoint, or small pupils (black part of the eye)
- continuing ringing or buzzing or other unexplained noise in the ears
- cool, pale skin
- depression
- diarrhea
- difficulty with moving
- disturbed color perception
- double vision
- excess air or gas in the stomach or intestines
- false or unusual sense of well-being
- flushed, dry skin
- fruit-like breath odor
- full feeling
- general feeling of discomfort or illness
- halos around lights
- hearing loss
- heartburn
- increased hunger
- increased urination
- indigestion
- joint pain
- lack or loss of strength
- muscle cramps or spasms
- muscle pain or stiffness
- night blindness
- nightmares
- overbright appearance of lights
- seeing, hearing, or feeling things that are not there
- seizures
- shakiness
- sleepiness or unusual drowsiness
- slurred speech
- stomach discomfort, upset, or pain
- sweating
- swollen joints
- thirst
- trouble sleeping
- tunnel vision
- unexplained weight loss
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
For Healthcare Professionals
Applies to acetaminophen / oxycodone: oral capsule, oral solution, oral tablet, oral tablet extended release
General
The most commonly reported adverse events have included lightheadedness, dizziness, drowsiness, sedation, nausea, and vomiting.[Ref]
Respiratory
Common (1% to 10%): Cough
Frequency not reported: Apnea, respiratory arrest, respiratory depression, hiccups
Postmarketing reports: Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, hypoventilation, laryngeal edema[Ref]
Hepatic
Oxycodone-acetaminophen:
Postmarketing reports: Transient elevations of hepatic enzymes, increased bilirubin, hepatic failure, jaundice, hepatotoxicity, hepatic disorder, hepatitis
Acetaminophen:
Frequency not reported: Hepatic necrosis[Ref]
At high doses, the most serious acetaminophen related adverse event is a dose-dependent, potentially fatal hepatic necrosis.[Ref]
Hypersensitivity
Frequency not reported: Skin eruptions, urticaria, erythematous skin reactions
Postmarketing reports: Anaphylaxis, allergic reaction, angioedema[Ref]
Dermatologic
Common (1% to 10%): Rash, blister, excoriation, pruritus, erythema
Frequency not reported: Dermatitis, ecchymosis, hyperhidrosis
Postmarketing reports: Urticaria, flushing, increased sweating[Ref]
Nervous system
Very common (10% or more): Dizziness (up to 13%)
Common (1% to 10%): Headache, somnolence
Frequency not reported: Lightheadedness, dizziness, drowsiness, sedation, migraine, myoclonus, paresthesia, tremor
Postmarketing reports: Stupor, cerebral edema, coma, subdural or intracranial hemorrhage, seizures
Opioids:
Postmarketing reports: Serotonin syndrome[Ref]
Psychiatric
Frequency not reported: Euphoria, dysphoria, insomnia, altered mood, sleep disorder, withdrawal syndrome
Postmarketing reports: Agitation, confusion, anxiety, mental impairment, drug dependence, drug abuse, depression, nervousness, hallucination, suicide[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 31%)
Common (1% to 10%): Vomiting, constipation, dry mouth, dyspepsia, diarrhea
Frequency not reported: Esophageal spasm, oropharyngeal pain, throat irritation
Postmarketing reports: Abdominal pain, abdominal distention, flatulence, gastrointestinal disorder, pancreatitis, intestinal obstruction, ileus, thirst[Ref]
Hematologic
Oxycodone-acetaminophen:
Frequency not reported: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia
Acetaminophen:
Rare (0.01% to 0.1%): Agranulocytosis[Ref]
Renal
Postmarketing reports: Renal insufficiency and failure[Ref]
Cardiovascular
Common (1% to 10%): Edema
Frequency not reported: Hypotension, chest discomfort
Postmarketing reports: Tachycardia, dysrhythmias, orthostatic hypotension, bradycardia, palpitations, hypertension[Ref]
Metabolic
Frequency not reported: Decreased appetite
Postmarketing reports: Hypoglycemia, hyperglycemia, acidosis, alkalosis, hyperkalemia, dehydration
Musculoskeletal
Postmarketing reports: Rhabdomyolysis, myalgia
Ocular
Postmarketing reports: Miosis, visual disturbances, red eye
Genitourinary
Common (1% to 10%): Dysuria
Frequency not reported: Urinary retention, interstitial nephritis, proteinuria, decreased urine flow
Other
Postmarketing reports: Malaise, asthenia, fatigue, fever, hypothermia, accidental overdose, non-accidental overdose, hearing loss, tinnitus[Ref]
Endocrine
Adrenal insufficiency and androgen deficiency have been reported with opioid use, most often with chronic use.
Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency
For Healthcare Professionals
Applies to acetaminophen / oxycodone: oral capsule, oral solution, oral tablet, oral tablet extended release
General
The most commonly reported adverse events have included lightheadedness, dizziness, drowsiness, sedation, nausea, and vomiting.[Ref]
Respiratory
Common (1% to 10%): Cough
Frequency not reported: Apnea, respiratory arrest, respiratory depression, hiccups
Postmarketing reports: Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, hypoventilation, laryngeal edema[Ref]
Hepatic
Oxycodone-acetaminophen:
Postmarketing reports: Transient elevations of hepatic enzymes, increased bilirubin, hepatic failure, jaundice, hepatotoxicity, hepatic disorder, hepatitis
Acetaminophen:
Frequency not reported: Hepatic necrosis[Ref]
At high doses, the most serious acetaminophen related adverse event is a dose-dependent, potentially fatal hepatic necrosis.[Ref]
Hypersensitivity
Frequency not reported: Skin eruptions, urticaria, erythematous skin reactions
Postmarketing reports: Anaphylaxis, allergic reaction, angioedema[Ref]
Dermatologic
Common (1% to 10%): Rash, blister, excoriation, pruritus, erythema
Frequency not reported: Dermatitis, ecchymosis, hyperhidrosis
Postmarketing reports: Urticaria, flushing, increased sweating[Ref]
Nervous system
Very common (10% or more): Dizziness (up to 13%)
Common (1% to 10%): Headache, somnolence
Frequency not reported: Lightheadedness, dizziness, drowsiness, sedation, migraine, myoclonus, paresthesia, tremor
Postmarketing reports: Stupor, cerebral edema, coma, subdural or intracranial hemorrhage, seizures
Opioids:
Postmarketing reports: Serotonin syndrome[Ref]
Psychiatric
Frequency not reported: Euphoria, dysphoria, insomnia, altered mood, sleep disorder, withdrawal syndrome
Postmarketing reports: Agitation, confusion, anxiety, mental impairment, drug dependence, drug abuse, depression, nervousness, hallucination, suicide[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 31%)
Common (1% to 10%): Vomiting, constipation, dry mouth, dyspepsia, diarrhea
Frequency not reported: Esophageal spasm, oropharyngeal pain, throat irritation
Postmarketing reports: Abdominal pain, abdominal distention, flatulence, gastrointestinal disorder, pancreatitis, intestinal obstruction, ileus, thirst[Ref]
Hematologic
Oxycodone-acetaminophen:
Frequency not reported: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia
Acetaminophen:
Rare (0.01% to 0.1%): Agranulocytosis[Ref]
Renal
Postmarketing reports: Renal insufficiency and failure[Ref]
Cardiovascular
Common (1% to 10%): Edema
Frequency not reported: Hypotension, chest discomfort
Postmarketing reports: Tachycardia, dysrhythmias, orthostatic hypotension, bradycardia, palpitations, hypertension[Ref]
Metabolic
Frequency not reported: Decreased appetite
Postmarketing reports: Hypoglycemia, hyperglycemia, acidosis, alkalosis, hyperkalemia, dehydration
Musculoskeletal
Postmarketing reports: Rhabdomyolysis, myalgia
Ocular
Postmarketing reports: Miosis, visual disturbances, red eye
Genitourinary
Common (1% to 10%): Dysuria
Frequency not reported: Urinary retention, interstitial nephritis, proteinuria, decreased urine flow
Other
Postmarketing reports: Malaise, asthenia, fatigue, fever, hypothermia, accidental overdose, non-accidental overdose, hearing loss, tinnitus[Ref]
Endocrine
Adrenal insufficiency and androgen deficiency have been reported with opioid use, most often with chronic use.
Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency
Further information
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.
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