Acetaminophen-hydrocodone Oral Tablet

• This drug has black box warnings. A black box warning is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
• May cause addiction, abuse, and misuse. Taking this drug increases your risk of opioid (narcotic) addiction, abuse, and misuse. This could lead to overdose and death. Talk to your doctor if you are concerned about the habit-forming properties of this drug.
• May slow or stop breathing. Hydrocodone in high doses may affect the parts of your brain that control your breathing. If you have trouble breathing, call your doctor or get emergency medical help right away.
• Accidental ingestion by children. Swallowing even one dose of this medication could be fatal to a child. Keep away from children.
• May cause withdrawal symptoms in newborn infants. If you use this medication during pregnancy, your baby may have life-threatening problems after it is born. This is called neonatal opioid withdrawal syndrome. Problems in your newborn are more likely if you take this medication for a long period of time during pregnancy. Talk to your doctor if you are pregnant or planning to become pregnant.
• Drug interactions. Hydrocodone and acetaminophen are broken down by your liver. If you take these drugs with another drug that can affect your liver, hydrocodone and acetaminophen could build up in your body and cause more breathing problems and other side effects. Your doctor may need to change or stop this medication or your other medications.
• May cause liver failure. Taking too much acetaminophen can cause liver failure. Sometimes, this results in the need for liver transplant, or death. Most reported cases of liver injury have occurred when a person took more than 4,000 mg of acetaminophen per day, usually together with more than one product containing acetaminophen. The risk of liver failure is higher in people who already have liver disease, and people who drink alcohol while taking acetaminophen.

Other warnings

• Severe allergic reaction warning: This medication may cause a severe, potentially life-threatening allergic reaction. The reaction can occur very quickly. Symptoms may include:
  • trouble breathing
  • swelling of your face, throat and mouth
  • rash
  • itching
  • vomiting

If this occurs, stop taking this medication and call your doctor right away or get emergency medical help.

• Adrenal gland problems warning: This medication may cause your adrenal glands to not work as well. Symptoms may include:
  • nausea
  • vomiting
  • loss of appetite
  • tiredness
  • weakness
  • dizziness
  • lightheadedness

If you have these symptoms, talk to your doctor. You may need to stop taking this medication or have some tests done.

This drug comes with several warnings.

Allergy warning

This drug can cause a severe allergic reaction. Symptoms may include:

• trouble breathing
• swelling of your throat or tongue
• hives
• rash
• itching

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Alcohol interaction warning

You shouldn’t drink alcohol while taking acetaminophen-hydrocodone. (The oral solution form of this medication also contains alcohol.) Drinking alcohol while taking this medication may cause:

• slowed or stopped breathing
• drowsiness
• tiredness
• mental cloudiness
• physical and mental slowing

Combining alcohol with this drug also increases your risk for liver problems and liver damage.

Warnings for people with certain health conditions

For people with head injury: If you have a head injury, hydrocodone may cause increased pressure in your brain and cause breathing problems.

For people with stomach problems: Use caution taking this drug if you have intestinal obstruction, ulcerative colitis, or constipation. This medication may ease your symptoms of these problems and make it difficult for doctors to diagnose or find the cause of the problems.

For people with severe kidney disease: If you have severe kidney problems, you might have trouble breathing if you take this medication.

For people with lung disease: If you have lung disease, you might have trouble breathing if you take this medication.

For people with severe liver disease: If you have severe liver disease, your risk of liver failure is increased. You may also have an increased chance to develop breathing problems.

For people with prostate enlargement: If you have an enlarged prostate, taking acetaminophen-hydrocodone may cause increased difficulty in urination.

For people with asthma: If you have severe or uncontrolled asthma, do not use this medication without talking to your doctor. You may have to take the first few doses in a monitored setting.

For pregnant women: This drug is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. Babies born to mothers who regularly take opioids such as hydrocodone may be born physically dependent on this drug. This can cause symptoms of withdrawal, or neonatal opioid withdrawal syndrome. Symptoms can include:

• excessive crying
• sneezing
• shaking
• rapid breathing
• increased bowel movements
• yawning
• vomiting
• fever

There’s also an increased chance that the baby may have trouble breathing if this medication is given to the mother shortly before giving birth.

For women who are breastfeeding: Acetaminophen is passed in small amounts in the breast milk, but its effects on breastfeeding children aren’t known. It isn’t known whether hydrocodone passes into breast milk.

Breastfeeding while taking this medication may come with risks. You and your doctor should decide whether you’ll take this medication or breastfeed.

For seniors: Older adults may have decreased kidney, liver, and heart function. If you’re a senior, your doctor may start you at a low dose of this medication.

For children: Always store this medication in containers with childproof lids that are securely closed. Keep this medication in a secure place, such as a locked medicine cabinet, even if you don't think your child can reach it.

Acetaminophen-hydrocodone is used for short- or long-term treatment. It comes with risks if you don’t take it exactly as prescribed by your doctor.

What to do if you miss a dose: If you’re taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it’s almost time for your next scheduled dose.

Don’t use extra medication to make up the missed dose. This could result in dangerous side effects.

If you take too much: If you take too much, you can overdose on this medication. You may experience:

• slowed or stopped breathing
• slowed heart rate
• very low blood pressure
• possible coma

You can also end up with liver damage or failure. If you experience nausea, vomiting, sweating, or an overall feeling of fatigue, call your doctor right away or get emergency medical help.

How to tell if the drug is working: Your pain should decrease.

Keep these considerations in mind if your doctor prescribes acetaminophen-hydrocodone for you.

General

• Take with food to lower your risk of upset stomach.
• You can cut or crush the oral tablet.

Storage

• Store this drug at temperatures ranging from 68°F to 77°F (20°C to 25°C).
• Keep this in a container with a child-resistant closure.
• Keep this drug away from light.

Refills

A prescription for this medication is not refillable. You or your pharmacy will have to contact your doctor for a new prescription if you need this medication refilled.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport x-ray machines. They can’t hurt your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

Your doctor may require liver and kidney function tests if you have severe liver or kidney disease.

• kidney function. Your doctor may do kidney tests if you have kidney problems to make sure that this medication is safe for you and won’t cause breathing problems.
• liver function. Your doctor may do liver tests if you have liver problems to make sure that this medication is safe for you and won’t cause breathing problems.

Prior authorization

Most insurance companies do not require a prior authorization for this drug.

There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.