hydrocodone / ibuprofen

• Risk factors: Personal or family history of substance or alcohol abuse | History of mental health conditions (like depression)

Hydrocodone/ibuprofen has a risk for addiction and misuse because it contains hydrocodone (an opioid). Addiction can develop even at recommended doses as prescribed or when hydrocodone/ibuprofen is used for reasons other than prescribed (misuse). Sometimes, addiction and misuse can lead to life-threatening overdose. To lower the risk for addiction and misuse, your provider will prescribe the lowest amount of hydrocodone/ibuprofen that's necessary for you for the shortest period of time possible.

Because of the risk for addiction and misuse, the FDA requires a Risk Evaluation and Mitigation Strategy (REMS) program for hydrocodone/ibuprofen. Under the Opioid Analgesic REMS program, your provider will talk to you about how to take hydrocodone/ibuprofen safely, what its risks are, and proper storage and disposal. These steps help keep you and your loved ones safe. Talk to your provider about other treatment options for pain if you have concerns about taking hydrocodone/ibuprofen.

• Risk factors: Age 65 years or older | Severe breathing problems like chronic obstructive pulmonary disease (COPD) | Sleep-related breathing problems (e.g., apnea) | Head injury | Severe weakness or muscle loss | Drinking alcohol | Taking medications that slow your body down | Taking high doses of hydrocodone/ibuprofen

Opioids like hydrocodone can cause extremely slowed breathing that can be deadly. This can happen at any time, even when the medication is used as recommended by your provider. But the risk is generally highest when you first start the medication or after your dose is raised. Don't take hydrocodone/ibuprofen with alcohol or other medications that can slow your body down (e.g., benzodiazepines, muscle relaxants). Doing so can slow down your breathing even more. Get medical help or call 911 right away if you or a loved one notices that you have trouble breathing; slow and shallow breathing; or bluish-colored lips, fingers, or toes.

• Risk factors: History of opioid use disorder | Previous opioid overdose | Taking medications that can slow the body down | Alcohol use | Taking high opioid doses | Taking more opioids than prescribed | Age 65 years or older | Age 18 years or younger

It's possible to accidentally take too much hydrocodone/ibuprofen, even at recommended doses of the medication. Overdoses can also happen if it's accidentally taken by a child or a loved one. Overdoses can be life-threatening if it's not recognized or treated in time. Your provider might recommend that you carry naloxone (Narcan) with you at all times to quickly, but temporarily reverse the effects of the medication if an accidental overdose happens. It's important for you and your caregiver to know how to use naloxone (Narcan) in case this happens. Opioid overdose symptoms include extremely slowed breathing, slow heartbeat, extreme sleepiness, cold or clammy skin, and not responding to sound or touch. Call 911 right away if you think an overdose has happened.

• Risk factors: History of heart problems | Recent heart attack | Heart bypass surgery in the last two weeks | Planned heart bypass surgery | Taking hydrocodone/ibuprofen for a long time

Hydrocodone/ibuprofen can raise your risk of having blood clots, heart attack, and stroke. Talk to your provider before starting this medication if you have heart problems, especially if you've recently had a heart attack or heart bypass surgery. To lower your risk, take hydrocodone/ibuprofen at the lowest dose and for the shortest amount of time possible. Don't take hydrocodone/ibuprofen if you've recently had or will be having heart surgery. Call 911 if you experience chest pain, trouble breathing, weakness on one side of your body, or trouble speaking or walking.

• Risk factors: Older adults | History of stomach bleeding or ulcers | Bleeding problems | Liver problems | Taking other medications that raise your risk for bleeds | Drinking alcohol | Smoking | Having poor health | Taking hydrocodone/ibuprofen for a long time

NSAIDs like ibuprofen can raise your risk for serious bleeding,ulcers, and tears in the stomach, gut, or esophagus (tube that leads from your mouth to your stomach). In some cases, this can be life-threatening. Serious stomach or gut problems can happen without warning while you're taking hydrocodone/ibuprofen. Your risk for stomach bleeds might be higher if you're also taking other medications that can cause bleeding, such as oral corticosteroids, blood thinners (anticoagulants), and other NSAIDS like aspirin.

Make sure your provider is aware of all of your medical conditions and medications before starting hydrocodone/ibuprofen so they can discuss with you about your risk for stomach or gut bleeds. Get medical help right away if you have severe stomach pain, black and tarry stools, or blood in your vomit or urine while using hydrocodone/ibuprofen.

Certain medications can interfere with how well your body gets rid of hydrocodone/ibuprofen. This can affect the amount of hydrocodone/ibuprofen in your body, how well it works, and the risk of side effects.

Some medications, like erythromycin (Ery-Tab) and ritonavir (Norvir), can raise the levels of hydrocodone/ibuprofen in your body. Higher levels can lead to potentially deadly slowed breathing. Other medications, such as rifampin (Rifadin) and carbamazepine (Tegretol), can lower the levels of hydrocodone/ibuprofen in your body. This can cause the pain medication to not work as well and lead to withdrawal.

If you're already taking stable doses of hydrocodone/ibuprofen with one of these other medications, don't stop taking them suddenly. Doing so can lead to unsafe hydrocodone/ibuprofen levels. Let your provider or pharmacist know what other medications you’re taking before starting hydrocodone/ibuprofen to make sure your medications are safe for you.

• Risk factors: Long-term use during pregnancy | Currently in second or third trimester of pregnancy

If you take opioids (like hydrocodone in hydrocodone/ibuprofen) for a long period of time during pregnancy, there's a risk that your unborn baby can become dependent on the medication. Once born, your baby can develop a condition called neonatal opioid withdrawal syndrome (NOWS) and experience withdrawal symptoms. Withdrawal symptoms in your newborn can include high-pitched crying, poor feeding and sucking behavior, trembling, irritability, and sometimes seizures. This condition can be life-threatening if not recognized and treated in time.

In addition, this medication can can cause harm to your unborn baby if it's taken after 20 weeks of pregnancy. NSAIDs (like ibuprofen in hydrocodone/ibuprofen) can cause serious complications, such as heart or kidney problems in your unborn baby, if they're taken during the second half of pregnancy.

Speak to your provider about the risks and benefits of taking hydrocodone/ibuprofen if you're pregnant. Let your provider know if you've used this medication during pregnancy or if you notice withdrawal symptoms in your baby. Ask whether there are safer alternatives.

• Risk factors: Age 65 years or older | Taking other medications that lower blood pressure or slow your body down| Dehydration or loss of body fluid through severe vomiting, bleeding, or diarrhea

Hydrocodone/ibuprofen can cause extremely low blood pressure, including a sudden drop in blood pressure when you stand from a sitting or lying down position. As a result, you might feel dizzy or even faint. To avoid falling, get up slowly if you've been sitting or lying down. If dizziness or lightheadedness doesn't go away, talk to your provider.

NSAIDs (like ibuprofen in hydrocodone/ibuprofen) can raise your blood pressure or cause swelling in the arms or legs. It can also put you at risk for heart failure or hospitalization from heart failure complications. This is because NSAIDs can cause your body to hold onto extra fluid. Some blood pressure or heart failure medications might not work as well when taken with hydrocodone/ibuprofen. Let your provider know if you have any heart problems (especially heart failure) or if you're taking medications for these conditions so they can make sure hydrocodone/ibuprofen is safe for you.

Check your blood pressure regularly while you're taking hydrocodone/ibuprofen, and let your provider know if you notice any changes. Also contact your provider if you experience trouble breathing, tiredness, swelling in your body, or sudden weight gain as these can be symptoms of heart failure.

• Risk factors: Older adults | Kidney or liver problems | Heart failure | Taking certain blood pressure medications (e.g., water pills, ACE inhibitors, ARBs) | Loss of body fluid through severe vomiting, bleeding, or diarrhea | Using hydrocodone/ibuprofen for a long time

Taking hydrocodone/ibuprofen for a long time can damage your kidneys by lowering blood flow to the kidneys. The risk of kidney damage is higher if you're taking certain blood pressure medications (like ACE inhibitors, ARBs, or water pills). Your risk might also be higher if you have certain medical conditions, such as kidney problems, liver problems, and heart failure. Kidney damage is usually reversible once you stop taking hydrocodone/ibuprofen. Tell your provider if you notice a change in how often you urinate after starting this medication since this can be a sign of kidney damage.

In addition, kidney damage from NSAIDs like ibuprofen can lead to high potassium levels. Sometimes, NSAIDs can cause high potassium levels even in people with healthy kidneys. Call your provider right away if you experience symptoms of high potassium levels, such as nausea, vomiting, muscle weakness, or tingling in your limbs because it can lead to dangerous health problems.

Some people have had liver damage while taking NSAIDs like the ibuprofen in hydrocodone/ibuprofen. Although rare, this liver damage can be life-threatening. Stop taking this medication and contact your provider right away if you experience signs and symptoms of liver problems, such as nausea, fatigue, itchiness, yellowing of your skin of whites of your eyes, pain on the upper right side of your stomach, or flu-like symptoms.

Some people taking opioid medications like hydrocodone/ibuprofen experienced a drop in their hormone levels. This is more likely to happen if you take the medication for more than a month. Symptoms of low hormone levels include nausea, loss of appetite, tiredness, weakness, and dizziness. Let your provider know if you have these symptoms.

• Risk factors: History of seizures

Opioids, such as hydrocodone in hydrocodone/ibuprofen, can more frequent seizures to happen in people who've had seizures in the past. The medication might also raise the risk of seizure in other situations where seizures can occur. Let your healthcare provider know if you have seizures more often while you're taking hydrocodone/ibuprofen.

• Risk factors: Long-term use of hydrocodone/ibuprofen

If you take hydrocodone/ibuprofen regularly for a long time, you can become physically dependent on the medication. This means your body starts to rely on the medication to function. And you might experience withdrawal if you suddenly lower your dose or stop taking the medication. Withdrawal symptoms can include restlessness, muscle pain, runny nose, yawning, sweating, chills, anxiety, and uncontrolled pain. Don't lower your dose or stop taking the medication suddenly without talking to your provider. To prevent withdrawal symptoms from happening, follow your provider's instructions carefully to slowly lower your dose. Talk to your provider about alternative pain medications if you have concerns about this risk.

Hydrocodone/ibuprofen can cause serious allergic reactions and skin reactions that can sometimes be life-threatening. Stop taking this medication and get medical help right away if you develop any type of rash, skin peeling, painful blisters, fever, swollen lymph nodes, facial swelling, trouble breathing, or anaphylaxis.

• Risk factors: Asthma | Stuffy nose with or without nasal polyps | History of allergic reaction to aspirin or other NSAIDs

Be careful using hydrocodone/ibuprofen if you have asthma. You might have worsening asthma symptoms while you're taking hydrocodone/ibuprofen if you have asthma or if you've had asthma attacks after taking aspirin or another NSAID. Get medical help right away if your throat tightens and you can't breathe.