1 What is Combunox?

Brand: Combunox

Generic: Oxycodone hydrochloride and Ibuprofen

Brand name:


Ibuprofen (NSAID) and oxycodone (opioid analgesic) combination are used for relief of acute, moderate to severe pain.

This drug combination works by relieving inflammation, swelling, and pain and also acts on the central nervous system to relieve pain.

The oxycodone component of this drug combination may result in dependence in prolonged uses.

However, this dependence usually does not occur if the oxycodone combination is only used for short-term. This drug requires a prescription.

2 What to Know Before Using

Before taking this drug, the risks and benefits for your body should be discussed with your healthcare provider.

Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children below 14 years of age have not been performed on the correlation of age to the effects of ibuprofen and oxycodone combination while safety and efficacy have not been established.

Studies in the elderly have not reported any geriatric-specific problems that would limit the usefulness of oxycodone and ibuprofen combination.

Adjustments in the dose of the elderly may be required since they are more sensitive than younger adults to the effects of ibuprofen and oxycodone combination, and are more likely to have kidney, lung, or stomach problems.

Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate.

A risk to the fetus has been determined in studies but the risks may be outweighed by the benefits of therapy in a life threatening situation or a serious disease.

Harmful infant effects have been reported in studies of breastfeeding women. Discuss with your healthcare professional about the risks and benefits of this drug before breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as

  • antihistamines
  • barbiturate anesthetics
  • barbiturates
  • cimetidine
  • narcotic pain medicine
  • phenothiazines
  • sodium oxybate
  • tranquilizers
  • anticoagulants
  • clopidogrel
  • corticosteroids
  • heparin
  • quinolone antibiotics
  • salicylates
  • anticholinergics
  • cyclosporine
  • MAOIs
  • probenecid
  • selective serotonin reuptake
  • tricyclic antidepressants
  • agonist/antagonist analgesics
  • naltrexone or rifampin
  • lithium
  • methotrexate
  • neuromuscular blockers
  • angiotensin-converting enzyme (ACE) inhibitors
  • loop diuretics
  • thiazide diuretics

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects.

Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

  • high blood pressure
  • blood disorders
  • bleeding or clotting problems
  • heart problems
  • swelling or fluid buildup
  • a recent heart attack
  • poor health
  • dehydration or low fluid volume
  • low blood sodium levels
  • mouth inflammation
  • liver or kidney problems
  • pancreas or gallbladder problems
  • thyroid problems
  • an enlarged prostate
  • trouble urinating
  • stomach or bowel problems
  • Addison disease, asthma, lung or breathing problems
  • tumors in the brain
  • increased pressure in the brain
  • a recent head injury
  • severe curvature of the spine
  • severe drowsiness
  • coma
  • recent surgery
  • lupus
  • seizures
  • mental or mood problems
  • suicidal thoughts or behavior

3 Proper Usage

This drug must be taken exactly as directed by your healthcare professional. To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional.

Follow the instructions on the label or as directed by your healthcare professional. The dose of this drug will be variable for different patients.

The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

Adults and teenagers 14 years of age and older with pain are prescribed with one tablet every 4 to 6 hours as needed.

The dose must not exceed 4 tablets per day, and should not be taken for longer than 7 days unless directed by your healthcare professional.

Use and dose in children and teenagers younger than 14 years of age must be determined by your healthcare professional. A missed dose should be taken as soon as possible.

However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.

Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Your health care provider should closely monitor the effectiveness of this drug as well as check for unwanted effects. Unwanted effects can be screened by blood tests.

Check with your healthcare professional before you take any other drugs. Your healthcare professional will check and monitor your blood pressure before you start treatment with this drug.

Serious heart problems may occur if high blood pressure occurs or worsens while taking this drug.

This drug may increase your risk of having a heart attack or stroke and is more likely to occur in prolonged use or people who already have heart disease.  

Contact emergency services immediately if you experience signs of serious heart problems such as chest pain, tightness in the chest, fast or irregular heartbeat, or unusual flushing or warmth of the skin.

Ibuprofen and oxycodone combination potentiates the effects of alcohol and other central nervous system (CNS) depressants such as antihistamines or drugs for hay fever, allergies, or colds, sedatives, tranquilizers, sleeping drug, or other prescription pain drug or narcotics, drug for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Alcohol intake is not recommended while taking this drug. Patients with a stomach ulcer in the past, smokers or regular alcohol drinkers, over 60 years of age, in poor health, or using certain other drugs such as steroids or a blood thinner taking this drug may have increased the risk of bleeding in your stomach or intestines.

Seek medical attention immediately if you experience symptoms of bleeding such as black, tarry stools, bloody stools, vomiting of blood or material that looks like coffee grounds, severe or continuing stomach pain, cramping, or burning, trouble breathing, severe or continuing nausea, heartburn and/or indigestion.

Consult with your healthcare professional immediately if you have symptoms of liver problems such as abdominal pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

Call emergency medical services immediately if you experience symptoms of anaphylaxis such as rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth, blistering, peeling, or loosening of the skin, red skin lesions, a severe skin rash or acne, sores or ulcers on the skin, or fever or chills while you are taking this drug.

This drug is teratogenic. Inform your healthcare professional immediately if you think you have become pregnant while using the drug.

Consult your healthcare professional before using this drug during the later part of a pregnancy. This drug may cause drowsiness, dizziness, lightheadedness, or feeling of a false sense of well-being.

Be careful in taking this drug before you drive, use machines, or do anything else that could be dangerous. Check with your healthcare professional if these reactions are inconvenient.

Inform your healthcare professional that you are taking this drug before having any kind of surgery or emergency treatment.

This drug combination may cause dryness of the mouth and for temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute.

Seek advice from your dentist if the dry mouth persists for more than 2 weeks as this may increase the chance of dental disease, including tooth decay, gum disease, and fungal infections.

Call your healthcare professional right away if you experience symptoms of meningitis such as confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting.

Inform your healthcare professional if you have heart disease or congestive heart failure, unexplained weight gain or edema with this drug.

Consult with your healthcare professional before you take any other prescription or non-prescription drugs and herbal or vitamin supplements.

5 Potential Side Effects

Side effects may vary for each individual and prompt medical attention should be given if they occur.

Consult with your healthcare professional immediately if you experience symptoms of:

  • feeling faint
  • dizzy or lightheaded
  • the feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • headache
  • sweating
  • abdominal or stomach pain
  • blurred vision
  • changes in skin color
  • chest pain
  • confusion
  • convulsions
  • the decrease in frequency of urination
  • decreased urine
  • the difficulty with breathing
  • difficulty in passing urine
  • dizziness
  • faintness or lightheadedness when getting up from a lying position
  • dry mouth
  • excessive muscle tone
  • fainting
  • fast heartbeat
  • 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
  • shortness of breath
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • any symptoms of overdose such as a 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
  • the difficulty with sleeping disorientation
  • drowsiness to profound coma
  • fainting
  • hallucination
  • 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
  • severe sleepiness
  • skeletal muscle flaccidity
  • sleepiness or unusual drowsiness
  • sudden fainting, or sudden loss of consciousness

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear.

Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional.

Report any side effects to the FDA hotline at 1-800-FDA-1088.