Oxycodone and Acetaminophen (Oral Route)

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Side Effects

Along with its needed effects, a medicine 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:

• 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
• Decrease in the frequency of urination
• Decrease in urine volume
• Decreased awareness or responsiveness
• Decreased frequency or amount of urine
• Decreased urination
• 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 or pulse
• Feeling of warmth
• General body swelling
• Greatly decreased frequency of urination or amount of urine
• Hives or welts
• Increase in heart rate
• Increased blood pressure
• Increased sweating
• Increased thirst
• Indigestion
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Lightheadedness
• Low body temperature
• 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 breathing
• Rapid, shallow breathing
• Redness of the face, neck, arms, and occasionally, upper chest
• Redness of the skin
• Restlessness
• Seizures
• Severe constipation
• Severe sleepiness
• Severe vomiting
• Shivering
• Shortness of breath
• Skin blisters
• Skin rash
• Sleepiness
• Slow or irregular breathing
• Sore throat
• Stomach cramps
• Stomach pain, continuing
• Sudden decrease in the amount of urine
• Sunken eyes
• Sweating
• Swelling in the legs and ankles
• Swelling of the face, fingers, or lower legs
• Thirst
• Tightness in the chest
• Tiredness
• Troubled breathing
• Unpleasant breath odor
• Upper right abdominal or stomach pain
• Vomiting
• Vomiting of blood
• Weak or feeble pulse
• Weakness or heaviness of the legs
• Weight gain
• Wheezing
• Wrinkled skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Bluish lips or skin
• Change in consciousness
• Cold, clammy skin
• Extreme sleepiness
• General feeling of discomfort or illness
• Loss of consciousness
• No blood pressure or pulse
• Not breathing
• Stopping of heart
• Unconsciousness

Some side effects 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:

• Relaxed and calm

• Acid or sour stomach
• Agitation
• Anxiety
• Bad or 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 thirst
• Increased urination
• Indigestion
• Joint pain
• Lack or loss of strength
• Muscle cramps or spasms
• Muscle pain or stiffness
• Nervousness
• Night blindness
• Nightmares
• Overbright appearance of lights
• Passing gas
• Rash
• Red eye
• Seeing, hearing, or feeling things that are not there
• Seizures
• Severe sleepiness
• Shakiness
• Sleepiness or unusual drowsiness
• Sleeplessness
• Slurred speech
• Stomach discomfort, upset, or pain
• Stomach fullness
• Sweating
• Swollen joints
• Thirst
• Trouble sleeping
• Troubled breathing
• Tunnel vision
• Unable to sleep
• Unexplained weight loss
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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