Note: This document contains side effect information about ibuprofen / oxycodone. Some dosage forms listed on this page may not apply to the brand name Combunox.
Applies to ibuprofen / oxycodone: oral tablet.
Warning
Oral route (Tablet)
Oxycodone hydrochloride/ibuprofen 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 or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of oxycodone hydrochloride/ibuprofen, especially in children, can result in fatal overdose of oxycodone hydrochloride and ibuprofen. Prolonged use of oxycodone hydrochloride/ibuprofen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Concomitant use of cytochrome P450 3A4 inhibitors or discontinuation of concomitantly used cytochrome P450 3A4 inducers may affect the plasma levels of oxycodone and lead to increased adverse reactions and fatal respiratory depression. Monitor patients carefully when oxycodone hydrochloride/ibuprofen and cytochrome P450 3A4 inhibitors and inducers are concurrently used. 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. NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Oxycodone hydrochloride/ibuprofen is contraindicated for use in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also increase the risk of serious gastrointestinal (GI) adverse events (eg, bleeding, ulceration, and perforation of the stomach or intestines) especially in the elderly and patients with a prior history of ulcer disease and/or GI bleeding, which can be fatal.
Serious side effects of Combunox
Along with its needed effects, ibuprofen / 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 ibuprofen / oxycodone:
Less common
- Feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- headache
- sweating
Rare
- Abdominal or stomach pain
- blurred vision
- changes in skin color
- chest pain
- confusion
- convulsions
- decrease in frequency of urination
- decreased urine
- difficulty in passing urine (dribbling)
- difficulty with breathing
- dizziness
- dizziness, faintness, or lightheadedness when getting up from a lying position
- dry mouth
- excessive muscle tone
- fainting
- fast, pounding, or irregular heartbeat or pulse
- increased need to urinate
- increased thirst
- loss of appetite
- mood changes
- muscle pain or cramps
- muscle stiffness
- muscle tension or tightness
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- pain, tenderness, or swelling of the foot or leg
- painful urination
- pale skin
- passing urine more often
- severe constipation
- severe vomiting
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
Get emergency help immediately if any of the following symptoms of overdose occur while taking ibuprofen / oxycodone:
Symptoms of overdose
- Change in consciousness
- chest pain or discomfort
- cold and clammy skin
- constricted pupils
- continuing ringing or buzzing or other unexplained noise in the ears
- decreased awareness or responsiveness
- difficult or troubled breathing
- difficulty with sleeping
- disorientation
- drowsiness to profound coma
- fainting
- hearing loss
- irregular, fast or slow, or shallow breathing
- lethargy
- loss of bladder control
- loss of consciousness
- muscle spasm or jerking of all extremities
- pale or blue lips, fingernails, or skin
- seeing, hearing, or feeling things that are not there
- severe sleepiness
- skeletal muscle flaccidity
- sleepiness or unusual drowsiness
- sudden fainting
- sudden loss of consciousness
Other side effects of Combunox
Some side effects of ibuprofen / 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:
Less common
- Acid or sour stomach
- belching
- bloated or full feeling
- diarrhea
- difficulty having a bowel movement (stool)
- excess air or gas in the stomach or intestines
- fever
- heartburn
- indigestion
- lack or loss of strength
- passing gas
- stomach discomfort, upset, or pain
Rare
- Back pain
- body aches or pain
- bruising, large, flat, blue or purplish patches in the skin
- changes in vision
- chills
- congestion
- cough or hoarseness
- delusions
- dementia
- difficult urination
- difficulty with moving
- dryness or soreness of the throat
- enlarged abdomen or stomach
- false or unusual sense of well-being
- fear
- hoarseness
- impaired vision
- increase in body movements
- lower back or side pain
- nervousness
- pain, swelling, or redness in the joints
- rash
- runny nose
- swelling
- taste perversion
- tender, swollen glands in the neck
- trouble with sleeping
- trouble with swallowing
- voice changes
For Healthcare Professionals
Applies to ibuprofen / oxycodone: oral tablet.
General
The most commonly reported adverse events have included nausea, vomiting, flatulence, somnolence, and dizziness.[Ref]
Gastrointestinal
Abdominal pain, enlarged abdomen, dry mouth, dyspepsia, eructation, and ileus, have been reported in less than 1% of patients.[Ref]
Common (1% to 10%): Nausea, vomiting, flatulence, constipation, diarrhea, dyspepsia
Frequency not reported: Abdominal pain, enlarged abdomen, dry mouth, eructation, ileus
Postmarketing reports:[Ref]
Cardiovascular
Hypotension, syncope, tachycardia, edema, and chest pain have been reported in less than 1% of patients.[Ref]
Common (1% to 10%): Vasodilation, thrombophlebitis
Frequency not reported: Hypotension, syncope, tachycardia, vasodilation, edema, chest pain[Ref]
Nervous system
Very common (10% or more): Dizziness (19.2%), somnolence (17.4%), headache (10.2%)
Common (1% to 10%): Hyperkinesia, hypertonia
Frequency not reported: Taste perversion
Postmarketing reports: Serotonin syndrome[Ref]
Respiratory
Frequency not reported: Respiratory depression[Ref]
Dermatologic
Common (1% to 10%): Sweat, rash[Ref]
Metabolic
Frequency not reported: Hypokalemia[Ref]
Hypersensitivity
Postmarketing reports: Anaphylaxis[Ref]
Hematologic
Common (1% to 10%): Ecchymosis
Frequency not reported: Anemia[Ref]
Psychiatric
Frequency not reported: Insomnia, euphoria, nervousness, abnormal thinking, anxiety[Ref]
Insomnia, euphoria, nervousness, abnormal thinking, and anxiety have been reported in less than 1% of patients.[Ref]
Endocrine
Postmarketing reports: Adrenal insufficiency, androgen deficiency
Adrenal insufficiency and androgen deficiency have been reported with opioid use, most often with chronic use.
Musculoskeletal
Frequency not reported: Arthritis, back pain[Ref]
Genitourinary
Frequency not reported: Urinary frequency[Ref]
Other
Common (1% to 10%): Fever, asthenia
Frequency not reported: Chills[Ref]
Ocular
Frequency not reported: Amblyopia[Ref]
