"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.
Vicoprofen Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Vicoprofen (hydrocodone and ibuprofen) is used short-term to relieve severe pain. This medication is not for treating arthritis pain. Hydrocodone is in a class of drugs called narcotic pain relievers. Ibuprofen is in a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). Vicoprofen is available in generic form. Common side effects include upset stomach, nausea, vomiting, constipation, dizziness, or drowsiness.
The dose of Vicoprofen is adjusted to the individual patient. Vicoprofen may adversely interact with antidepressants, MAO inhibitors, aspirin or other NSAIDs, ACE inhibitors, lithium, bronchodilators, diuretics (water pills), corticosteroids, blood thinners, methotrexate, injected narcotic medication, atropine, scopolamine, or bowel or bladder medications. Discuss all medications you are taking with your doctor. During the first 6 months of pregnancy, this medication should be used only when prescribed by a doctor. It is not recommended during the last 3 months of pregnancy due to possible harm to the fetus and interference with normal labor/delivery. Use of this medication near or at the time of delivery may have side effects (such as slow/shallow breathing) on the newborn. Babies born to mothers who have used this medication may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice any of these symptoms in your newborn, tell the doctor promptly. Vicoprofen passes into breast milk and may have effects on a nursing infant. Consult your doctor before breast-feeding. Vicoprofen may cause withdrawal reactions. Withdrawal symptoms (restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal, your doctor may reduce your dose gradually. Report any withdrawal reactions to your doctor immediately.
Our Vicoprofen Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
Vicoprofen 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.
Call your doctor at once if you have any of these serious side effects:
- chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
- sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;
- black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- swelling or rapid weight gain;
- shallow breathing, slow heartbeat;
- confusion, feeling light-headed, fainting;
- easy bruising or bleeding;
- nausea, stomach pain, loss of appetite, itching, 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 may include:
- headache, dizziness, drowsiness;
- mild nausea, vomiting, upset stomach, 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 Vicoprofen (Hydrocodone and Ibuprofen) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Vicoprofen Overview - Patient Information: Side Effects
Upset stomach, nausea, vomiting, constipation, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To prevent constipation, eat 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).
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
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 right away if you have any serious side effects, including: easy bruising/bleeding, fast/pounding heartbeat, difficult/painful swallowing, mental/mood changes, difficulty urinating, swelling of hands/feet, sudden/unexplained weight gain, unusual weakness, unusual tiredness.
Stop taking this medication and get medical help right away if any of these rare but serious side effects occur: fainting, slow/irregular/shallow breathing, change in amount of urine, unusual drowsiness/difficulty waking up, unexplained fever, persistent/severe headache, unexplained stiff neck.
This drug may rarely cause serious, possibly fatal, liver disease. Stop taking this medication and get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash/blisters, 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 Vicoprofen (Hydrocodone and Ibuprofen)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Vicoprofen FDA Prescribing Information: Side Effects
VICOPROFEN (hydrocodone and ibuprofen) was administered to approximately 300 pain patients in a safety study that employed dosages and a duration of treatment sufficient to encompass the recommended usage (see DOSAGE AND ADMINISTRATION). Adverse event rates generally increased with increasing daily dose. The event rates reported below are from approximately 150 patients who were in a group that received one tablet of VICOPROFEN (hydrocodone and ibuprofen) an average of three to four times daily. The overall incidence rates of adverse experiences in the trials were fairly similar for this patient group and those who received the comparison treatment, acetaminophen 600 mg with codeine 60 mg.
The following lists adverse events that occurred with an incidence of 1% or greater in clinical trials of VICOPROFEN (hydrocodone and ibuprofen) , without regard to the causal relationship of the events to the drug. To distinguish different rates of occurrence in clinical studies, the adverse events are listed as follows:
name of adverse event = less than 3%
adverse events marked with an asterisk * = 3% to 9%
adverse event rates over 9% are in parentheses.
Body as a Whole
Central Nervous System
Metabolic and Nutritional Disorders
Skin and Appendages
Incidence less than 1%
Body as a Whole Allergic reaction.
Central Nervous System
Metabolic and Nutritional
Skin and Appendages
Altered vision; Bad taste; Dry eyes.
Drug Abuse and Dependence
Misuse Abuse and Diversion of Opioids
VICOPROFEN (hydrocodone and ibuprofen) contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. VICOPROFEN (hydrocodone 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. VICOPROFEN (hydrocodone 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 Vicoprofen (Hydrocodone and Ibuprofen) »
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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.
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