Hydrocodone and ibuprofen (Oral route)
hye-droe-KOE-done bye-TAR-trate, eye-bue-PROE-fen
Addiction, Abuse, and MisuseHydrocodone bitartrate/ibuprofen exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing hydrocodone bitartrate/ibuprofen, and monitor all patients regularly for the development of these behaviors and conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate/ibuprofen. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate/ibuprofen or following a dose increase.Accidental IngestionAccidental ingestion of even one dose of hydrocodone bitartrate/ibuprofen, especially by children, can result in a fatal overdose of hydrocodone bitartrate.Neonatal Opioid Withdrawal SyndromeProlonged use of hydrocodone bitartrate/ibuprofen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. 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.Cytochrome P450 3A4 InteractionThe concomitant use of hydrocodone bitartrate/ibuprofen with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Monitor patients taking hydrocodone bitartrate/ibuprofen and any CYP3A4 inhibitor or upon discontinuation of a CYP3A4 inducer for signs and symptoms of respiratory depression and sedation.Risks From Concomitant Use With Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of hydrocodone bitartrate/ibuprofen and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.Cardiovascular Thrombotic EventsNonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and increase with duration of use. Hydrocodone bitartrate/ibuprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.Gastrointestinal Bleeding, Ulceration, and PerforationNSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events .
Uses of This Medicine:
Hydrocodone and ibuprofen combination is used to relieve acute pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. This medicine should only be used for short periods of time, usually for a total of less than 10 days. This combination is not used for osteoarthritis or rheumatoid arthritis.
Hydrocodone is a narcotic analgesic that acts on the central nervous system to relieve pain. If hydrocodone is used for a long time, it may become habit-forming (causing mental or physical dependence). However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects when you stop taking the medicine. Since hydrocodone and ibuprofen combination is only used for short-term (10 days or less) relief of pain, physical dependence will probably not occur.
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used in this combination to relieve inflammation, swelling, and pain.
This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of hydrocodone and ibuprofen combination in children younger than 16 years of age. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone and ibuprofen combination in the elderly. However, elderly patients are more likely to develop age-related kidney, lung, or stomach problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amtolmetin Guacil
- Bismuth Subsalicylate
- Chloral Hydrate
- Choline Magnesium Trisalicylate
- Choline Salicylate
- Dabigatran Etexilate
- Eslicarbazepine Acetate
- Ethacrynic Acid
- Flufenamic Acid
- Magnesium Salicylate
- Mefenamic Acid
- Methylene Blue
- Morphine Sulfate Liposome
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Nitrous Oxide
- Opium Alkaloids
- Pentosan Polysulfate Sodium
- Phenyl Salicylate
- Protein C
- Salicylic Acid
- Sodium Oxybate
- Sodium Salicylate
- St John's Wort
- Tenofovir Disoproxil Fumarate
- Tiaprofenic Acid
- Tolfenamic Acid
- Tolonium Chloride
- Trolamine Salicylate
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Azilsartan Medoxomil
- Candesartan Cilexetil
- Olmesartan Medoxomil
- Perindopril Erbumine
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison's disease (adrenal gland problem) or
- Alcohol abuse, or history of or
- Brain tumor or
- Breathing problems (eg, COPD, cor pulmonale, hypercapnia, hypoxia) or
- Depression, or history of or
- Drug abuse or dependence, especially narcotics, or history of or
- Enlarged prostate (BPH, prostatic hypertrophy) or
- Head injury, history of or
- Hypothyroidism (underactive thyroid) or
- Kidney disease, severe or
- Liver disease, severe or
- Problems with urination or
- Systemic lupus erythematosus (SLE) or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Anemia or
- Bleeding problems or
- Edema (fluid retention) or
- Gallbladder problems or
- Heart attack, history of or
- Heart disease (eg, congestive heart failure) or
- Hypertension (high blood pressure) or
- Hypotension (low blood pressure) or
- Kidney disease or
- Liver disease or
- Pancreatitis (swelling of the pancreas) or
- Seizures, history of or
- Stomach ulcers or bleeding, history of or
- Stroke, history of—Use with caution. May make these conditions worse.
- Aspirin-sensitive asthma or
- Aspirin sensitivity, history of or
- Lung breathing problems (eg, asthma, respiratory depression), severe or
- Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.
- Heart surgery (eg, coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.
Proper Use of This Medicine:
For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. Taking too much of this medicine may increase the chance of unwanted effects.
It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of hydrocodone and ibuprofen combination. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.
Swallow the tablet whole. Do not crush, break, or chew it.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For pain:
- Adults and children 16 years of age and older—1 tablet every 4 to 6 hours as needed. However, the dose is usually not more than 5 tablets per day.
- Children younger than 16 years of age—Use and dose must be determined by your doctor.
- For pain:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a safe and secure place. Do not throw unused medicine in the trash. Flush any unused tablets down the toilet. Ask your pharmacist about the best way to dispose of medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Avoid using this medicine and an MAO inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within 14 days of each other.
This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Some signs of serious heart problems are chest pain, tightness in the chest, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Check with your doctor right away if you notice any of these warning signs.
This medicine may cause bleeding in your stomach or bowels. This problem can happen without warning signs. This is more likely to occur if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (eg, steroids or a blood thinner). Call your doctor right away if you have severe stomach pain, black, tarry stools, or are vomiting blood or material that looks like coffee grounds.
Liver problems may occur while you are using this medicine. Check with your doctor right away if you have more than one of these symptoms: abdominal or stomach 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.
This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
Using an NSAID medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.
Hydrocodone and ibuprofen combination will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, sleeping medicine, or other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above while you are using this medicine.
This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these reactions are especially bothersome, check with your doctor.
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.
Hydrocodone and ibuprofen combination may cause dry mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if you take this medicine for a long time and dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.
If you have heart disease or congestive heart failure (CHF), tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.
Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
This medicine may cause constipation. This is more common if you use it for a long time. Ask your doctor if you should also use a laxative to prevent and treat constipation.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- Bloody stools
- burning feeling in the chest or stomach
- congestion in the chest
- changes in facial skin color
- difficulty with swallowing
- fast or irregular breathing
- frequent urge to urinate
- inability to urinate
- irregular heartbeat
- lightheadedness or dizziness
- loss of bladder control
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- ringing or buzzing in the ears
- tightness in the chest
- troubled breathing
- skin rash, hives, or itching
- stomach pain
- tenderness in the stomach
- visual disturbances
- Incidence not known
- darkening of the skin
- difficulty swallowing
- loss of appetite
- mental depression
- overactive reflexes
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- talking or acting with excitement you cannot control
- trembling or shaking
- unusual tiredness or weakness
- Symptoms of overdose
- Blurred vision
- cold or clammy skin
- difficulty hearing or ringing or buzzing in the ears
- general feeling of illness
- mood or mental changes
- severe drowsiness
- severe stomach pain
- skin rash
- slow heartbeat
- slow or troubled breathing
- stiff neck or back
- swelling of the face, fingers, feet, or lower legs
- More common
- dry mouth
- increased sweating
- pounding heartbeat
- trouble in sleeping
- Decreased appetite
- decrease in sexual ability
- increased thirst
- mood or mental changes
- mouth ulcers
- pain or burning in the throat
- runny nose
- sensation of burning, warmth, heat, numbness, tightness, or tingling
- slurred speech
- stomach upset
- thinking abnormalities
- unexplained weight loss
- unusual feeling of well-being
Along with its needed effects, a medicine 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:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects 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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 8/2/2019