Hydrocodone/ibuprofen has a high risk for abuse and severe, possibly fatal, breathing problems. The risk for harm is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Be sure you know how to take hydrocodone/ibuprofen and what other drugs you should avoid taking with it. See also Drug Interactions section. To lower your risk, your doctor should have you take the smallest dose of hydrocodone/ibuprofen that works, and take it for the shortest possible time. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.
The other ingredient in this medication, ibuprofen, may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. Also, nonsteroidal anti-inflammatory drugs (including ibuprofen) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while taking this drug but is more likely if you take it for a long time. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). Do not take this drug right before or after heart bypass surgery (CABG). Talk to your doctor or pharmacist about the benefits and risks of treatment, as well as other possible medication choices.
Stop taking this medication and get medical help right away if you notice any of the following rare but very serious side effects: chest pain, severe dizziness, weakness on one side of the body, vision changes, slurred speech, black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds. (See also Precautions section.)
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. If this medication must be used, to lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.Who should not take hydrocodone-ibuprofen?
This combination medication is used for a short time (usually less than 10 days) to help relieve moderate to severe pain. It contains an opioid (narcotic) pain reliever (hydrocodone) and a nonsteroidal anti-inflammatory drug-NSAID (ibuprofen). Hydrocodone works in the brain to change how your body feels and responds to pain. Ibuprofen reduces pain and fever.
This product is not recommended for use in children younger than 6 years due to an increased risk of serious side effects (such as slow/shallow breathing).
This medication is not intended to treat long-term conditions (such as arthritis).
Take this medication by mouth as directed by your doctor, usually every 4 to 6 hours as needed. Take it with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for 10 minutes after taking this drug. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).
The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed. The manufacturer recommends you take no more than 5 tablets in a 24-hour period.
Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well. Also follow your doctor's or pharmacist's directions for the safe use of other non-narcotic pain relievers (such as acetaminophen).
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Ask your doctor or pharmacist for more details, and report any withdrawal reactions right away.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your pain persists or worsens.
See also Warning section.
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 (such as agitation, confusion, hallucinations), difficulty urinating, swelling of hands/feet, sudden/unexplained weight gain, unusual weakness, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).
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, signs of kidney problems (such as change in the amount of urine), severe drowsiness/difficulty waking up, unexplained fever, persistent/severe headache, unexplained stiff neck, seizure.
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 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking this medication, tell your doctor or pharmacist if you are allergic to ibuprofen or hydrocodone; or to aspirin or other NSAIDs (such as naproxen, celecoxib); or to opioid pain medications (such as codeine, morphine, hydromorphone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), low red blood cell count (anemia), bleeding or clotting problem, brain disorders (such as head injury, tumor, seizures, stroke), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), growths in the nose (nasal polyps), high blood pressure, heart problems (such as irregular heartbeat, recent heart attack), liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as ulcer, blockage, constipation, diarrhea due to infection, paralytic ileus), fluid retention/swelling of the ankles/feet/hands, difficulty urinating (such as due to enlarged prostate), gallbladder disease, disease of the pancreas (pancreatitis).
Kidney problems can sometimes occur with the use of NSAID medications, including ibuprofen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Avoid alcohol and stop smoking. Consult your doctor or pharmacist for more information.
Children may be more sensitive to the side effects of this drug, especially slow/shallow breathing.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)
This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.
See also Warning section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), corticosteroids (such as prednisone), lithium, opioid antagonists (such as naltrexone, naloxone), pemetrexed, probenecid, certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol).
This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.
Other medications can affect the removal of hydrocodone/ibuprofen from your body, which may affect how hydrocodone/ibuprofen works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), HIV medications (such as ritonavir), rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.
Check all prescription and nonprescription medicine labels carefully for ibuprofen or other pain/fever drugs (aspirin, NSAIDs such as celecoxib, ketorolac, or naproxen). These drugs are similar to ibuprofen, so taking one of these drugs while also taking ibuprofen may increase your risk of side effects. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise.
Daily use of ibuprofen may decrease aspirin's ability to prevent heart attack/stroke. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain. If you must take ibuprofen, talk to your doctor about possibly taking immediate-release aspirin (not enteric-coated/EC) while taking ibuprofen. Take this product at least 8 hours before or at least 30 minutes after your aspirin dose. Do not increase your daily dose of aspirin or change the way you take aspirin/other medications without your doctor's approval.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, oxycodone), alcohol, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, fast/slow/irregular heartbeat, coma.
Laboratory and/or medical tests (such as kidney function tests) may be performed to check for side effects. Consult your doctor for more details.
This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.
If you are taking this product on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Different brands of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised November 2016. Copyright(c) 2016 First Databank, Inc.
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