"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
Combunox Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Combunox in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using ibuprofen and oxycodone and call your doctor at once if you have a serious side effect such as:
- chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
- black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee ground;
- swelling or rapid weight gain;
- shallow breathing, slow heartbeat;
- confusion, feeling light-headed, fainting;
- easy bruising or bleeding;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- severe blistering, peeling, and red skin rash; or
- fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).
Less serious side effects include:
- headache, dizziness, drowsiness;
- mild nausea, vomiting, upset stomach, bloating, gas, constipation, diarrhea;
- blurred vision; or
- dry mouth.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Combunox (Oxycodone HCl and Ibuprofen) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Combunox Overview - Patient Information: Side Effects
Nausea, vomiting, constipation, dizziness, drowsiness, upset stomach, or weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/irregular/shallow breathing, dizziness upon standing, fainting, swelling of the hands or feet, sudden or unexplained weight gain, fast/pounding heartbeat, persistent/severe headache, mental/mood changes, difficult/painful swallowing, unusual tiredness.
Tell your doctor immediately if any of these rare but very serious side effects occur: change in amount of urine, easy bruising/bleeding, signs of infection (such as fever, persistent sore throat), severe stomach/abdominal pain, ringing in the ears, unexplained stiff neck, seizures.
This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking this medication and consult your doctor or pharmacist immediately: yellowing eyes/skin, dark urine, persistent nausea/vomiting.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Combunox (Oxycodone HCl and Ibuprofen)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Combunox FDA Prescribing Information: Side Effects
Listed below are the adverse event incidence rates from single dose analgesia trials in which a total of 2437 patients received either Combunox (oxycodone hcl and ibuprofen) , ibuprofen (400 mg), oxycodone HCl (5 mg), or placebo. Adverse event information is also provided from an additional 334 patients who were exposed to Combunox (oxycodone hcl and ibuprofen) in a multiple dose analgesia trial, without placebo or active component comparison arms, given up to four times daily for up to 7 days.
Adverse Events Which Occurred at a Frequency of ≥ 1% and
at a Higher Incidence than in the Placebo Group in Single Dose Studies
HCl (n = 286)
|Nausea||81 (8.8%)||44 (4.8%)||46 (16.1%)||21 (6.7%)|
|Vomiting||49 (5.3%)||16 (1.8%)||30 (10.5%)||10 (3.2%)|
|Flatulence||9 (1.0%)||7 (0.8%)||3 (1.0%)||0|
|Somnolence||67 (7.3%)||38 (4.2%)||12 (4.2%)||7 (2.2%)|
|Dizziness||47 (5.1%)||21 (2.3%)||17 (5.9%)||8 (2.5%)|
|Skin and Appendages|
|Sweat||15 (1.6%)||7 (0.8%)||4 (1.4%)||1 (0.3%)|
Adverse events that were reported by at least 1% of patients taking Combunox (oxycodone hcl and ibuprofen) but were observed at a greater incidence in the placebo treated patients were fever, headache and pruritus.
Adverse events that occurred in less than 1% and in at least two Combunox (oxycodone hcl and ibuprofen) treated patients in Single Dose studies not listed above include the following: Body as Whole: abdominal pain, asthenia, chest pain, enlarged abdomen. Cardiovascular System: hypotension, syncope, tachycardia, vasodilation. Digestive System: constipation, dry mouth, dyspepsia, eructation, ileus. Hemic and Lymphatic System: anemia. Metabolic and Nutritional Disorders: edema. Nervous System: euphoria, insomnia, nervousness. Respiratory System: hypoxia, lung disorder, pharyngitis. Urogenital System: urinary retention.
Adverse events that occurred in the Multiple Dose study in at least 2% of patients treated with Combunox (oxycodone hcl and ibuprofen) include the following: Body as Whole: asthenia (3.3%), fever (3.0%), headache (10.2%). Cardiovascular System: vasodilation (3.0%). Digestive System: constipation (4.5%), diarrhea (2.1%), dyspepsia (2.1%), nausea (25.4%), vomiting (4.5%). Nervous System: dizziness (19.2%), somnolence (17.4%).
Adverse events that occurred in less than 2% of and at least two Combunox (oxycodone hcl and ibuprofen) treated patients in the Multiple Dose study not listed previously include the following: Body as Whole: back pain, chills, infection. Cardiovascular System: thrombophlebitis. Hemic and Lymphatic System: ecchymosis. Metabolic and Nutritional Disorders: hypokalemia. Musculoskeletal System: arthritis. Nervous System: abnormal thinking, anxiety, hyperkinesia, hypertonia. Skin and Appendages: rash. Special Senses: amblyopia, taste perversion. Urogenital System: urinary frequency.
Drug Abuse And Dependence
Combunox (oxycodone hcl and ibuprofen) contains oxycodone, which is a mu-opioid agonist with an abuse liability similar to other opioid agonists and is a Schedule II controlled substance. Combunox (oxycodone hcl and ibuprofen) , and other opioids used in analgesia, can be abused and are subject to criminal diversion.
Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common.
“Drug seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Combunox (oxycodone hcl and ibuprofen) , like other opioids, may be diverted for non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Read the entire FDA prescribing information for Combunox (Oxycodone HCl and Ibuprofen) »
Additional Combunox Information
Combunox - User Reviews
Combunox User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Chronic Pain/Back Pain
Find tips and advances in treatment.