Xtampza Er

Note: This document contains side effect information about oxycodone. Some of the dosage forms listed on this page may not apply to the brand name Xtampza ER.

Common side effects of Xtampza ER include: constipation, drowsiness, nausea, pruritus, and vomiting. Other side effects include: asthenia, diaphoresis, and xerostomia. See below for a comprehensive list of adverse effects.

Applies to oxycodone: oral capsule, oral capsule extended release, oral solution, oral tablet, oral tablet extended release

Along with its needed effects, oxycodone (the active ingredient contained in Xtampza ER) 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 oxycodone:

Less common

• Chills
• cold sweats
• confusion
• difficult or labored breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• tightness in the chest
• twitching

Rare

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine
• burning while urinating burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• cough
• decrease in the frequency of urination
• decreased urine output
• difficult or painful urination
• difficulty in passing urine (dribbling)
• difficulty with swallowing
• dizziness
• dry mouth
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• frequent urination
• headache
• hives, itching, or skin rash
• increase in heart rate
• increased thirst
• increased volume of pale, dilute urine
• lightheadedness
• muscle pain or cramps
• nausea
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid breathing
• rapid weight gain
• seizures
• severe constipation
• severe vomiting
• stomach pain
• sunken eyes
• sweating
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• thirst
• trembling or shaking of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• wrinkled skin

Incidence not known

• Blurred vision
• choking
• clay-colored stools
• cold, clammy skin
• dark urine
• diarrhea
• fast, weak pulse
• gagging
• irregular, fast, slow, or shallow breathing
• loss of appetite
• pale or blue lips, fingernails, or skin
• unconsciousness
• unpleasant breath odor
• very slow heartbeat
• yellow eyes or skin

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

Symptoms of overdose

• Change in consciousness
• chest pain or discomfort
• constricted, pinpoint, or small pupils (black part of the eye)
• decreased awareness or responsiveness
• extreme drowsiness
• loss of consciousness
• no muscle tone or movement
• severe sleepiness
• slow or irregular heartbeat

Some side effects of 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

• Difficulty having a bowel movement
• drowsiness
• lack or loss of strength
• relaxed and calm feeling
• sleepiness or unusual drowsiness

Less common

• Abnormal dreams
• anxiety
• belching
• burning feeling in the chest or stomach
• false or unusual sense of well-being
• heartburn
• hiccups
• indigestion
• stomach discomfort or upset
• tenderness in the stomach area
• trouble sleeping
• weight loss

Rare

• Absent, missed, or irregular menstrual periods
• bad, unusual or unpleasant (after) taste
• bloated or full feeling
• body aches or pain
• change in taste
• change in walking and balance
• changes in vision
• clumsiness or unsteadiness
• congestion
• continuous ringing or buzzing or other unexplained noise in the ears
• crying
• decreased interest in sexual intercourse
• deep or fast breathing with dizziness
• delusions of persecution, mistrust, suspiciousness, or combativeness
• dental caries or tooth decay
• depression
• difficulty with speaking
• dry skin
• dryness or soreness of the throat
• excess air or gas in the stomach or intestines
• excessive muscle tone
• feeling of constant movement of self or surroundings
• feeling of unreality
• general feeling of discomfort or illness
• headache, severe and throbbing
• hearing loss
• hoarseness
• inability to have or keep an erection
• increase in body movements
• increased appetite
• increased cough
• irritability
• loss in sexual ability, desire, drive, or performance
• loss of heat from the body
• loss of memory
• loss of strength or energy
• muscle pain or weakness
• muscle stiffness, tension, or tightness
• neck pain
• numbness of the feet, hands, and around the mouth
• passing of gas
• problems with memory
• quick to react or overreact emotionally
• rapidly changing moods
• red, swollen skin
• restlessness
• runny nose
• scaly skin
• sensation of spinning
• sense of detachment from self or body
• severe sleepiness
• swelling or inflammation of the mouth
• voice changes

Applies to oxycodone: compounding powder, oral capsule, oral capsule extended release, oral concentrate, oral solution, oral tablet, oral tablet extended release

The most commonly reported adverse reactions in adults included constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating. In pediatric patients, the most frequently observed adverse reactions included vomiting, nausea, headache, pyrexia, and constipation.

Very common (10% or more): Headache (14%, pediatrics)

Common (1% to 10%): Dizziness (pediatrics)

Frequency not reported: Confusion, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, migraine

Postmarketing reports: Serotonin syndrome

Severe adverse effects such as respiratory depression can be treated with the opioid antagonist naloxone.

Frequency not reported: Apnea, respiratory arrest, bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, sinusitis

Very common (10% or more): Nausea (23% to 27%), constipation (23% to 26%), vomiting (12% to 14%)

Frequency not reported: Abdominal pain, anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis

In pediatric studies with the oral extended release product, gastrointestinal adverse events were reported in 40% of patients 11 to 16 years of age (56 of 140); vomiting, nausea, constipation, and diarrhea were experienced by 21%, 15%, 9%, and 6%, respectively. Abdominal pain and gastroesophageal reflux disease were reported in 1% to less than 5% of patients.

Frequency not reported: Paranoia, psychosis, hallucinations, agitation, anxiety

Common (1% to 10%): Pruritus, hyperhidrosis, rash

Frequency not reported: Herpes simplex, rash, sweating, urticaria

Frequency not reported: Increased hepatic enzymes

Frequency not reported: QTc prolongation at higher doses, deep thrombophlebitis, heart failure, hemorrhage, hypotension, palpitation, tachycardia, edema, peripheral edema, vasodilation, circulatory collapse

Common (1% to 10%): Dysuria, urinary retention

Frequency not reported: Urinary tract infection

Frequency not reported: Allergic reaction

Postmarketing reports: Anaphylaxis

Frequency not reported: Flu syndrome, infection, sepsis

Common (1% to 10%): Decreased appetite (pediatrics)

Frequency not reported: Gout, hyperglycemia, iron deficiency anemia

Frequency not reported: Back pain, neck pain, arthralgia, arthritis, bone pain, myalgia, pathological fracture

Frequency not reported: Photosensitivity reaction, amblyopia

Very common (10% or more): Pyrexia (11%, pediatrics)

Frequency not reported: Chills and fever, accidental injury

Opioids:

Postmarketing reports: Adrenal insufficiency, androgen deficiency