acetaminophen / codeine

• Risk factors: History of alcohol use disorder | History of substance use disorder

Opioids like Tylenol with Codeine have a risk of misuse, addiction, and dependence. Addiction and dependence can happen even when the medication is taken as prescribed. And misuse can lead to an opioid overdose. Your prescriber will give you the lowest dose needed for the shortest time that’s right for you.

Because of these risks, Tylenol with Codeine is part of an FDA Risk Evaluation and Mitigation Strategies (REMS) program. This program helps you and your care team understand the risks of opioids. Your prescriber will explain how to take, store, and get rid of Tylenol with Codeine safely. This helps keep you and your loved ones safe.

Take Tylenol with Codeine exactly as prescribed. Don’t change your dose or how often you take it without talking to your prescriber first.

• Risk factors: Age 65 or older | Under age 12 | Under age 18 after tonsil or adenoid surgery | Chronic obstructive pulmonary disease (COPD) or other breathing problems | Head injury, brain tumors, or other conditions related to brain function | Opioids or other sedating medications | Alcohol use | Ultra-rapid metabolizers of codeine

Tylenol with Codeine can cause dangerously slow breathing, which can be life-threatening. It can happen at any time, but the risk is greatest when you first start treatment or right after your dose goes up. Your body changes some codeine into morphine. This can happen faster than expected in some people and raise the risk of serious breathing problems.

The risk is also higher if you take other medications that can slow your breathing. This includes benzodiazepines and other opioids. Drinking alcohol with Tylenol with Codeine also raises the risk.

Your prescriber might recommend keeping naloxone (Narcan) with you. It can quickly reverse an opioid overdose, including dangerously slow breathing. Make sure you and your loved ones know how to use naloxone. Give naloxone and call 911 right away if you have trouble breathing, your lips turn blue, or you can't be woken up.

• Risk factors: History of opioid use disorder | Previous opioid overdose | Taking more opioids than prescribed | Taking sedatives or other medications that can cause slowed breathing | Drinking alcohol | Accidental exposure in children

Take Tylenol with Codeine exactly as prescribed. Taking too much or taking it more often than prescribed can lead to an opioid overdose. An overdose can also happen if a child accidentally takes the medication.

An opioid overdose can be life-threatening. Be sure you and your loved ones know the signs. These can include very slow or stopped breathing, a slow heartbeat, extreme sleepiness, cold or clammy skin, or not waking up.

Your prescriber might suggest keeping naloxone (Narcan) on hand. Naloxone can reverse an opioid overdose. Make sure you and your loved ones know when and how to use it.

If you think someone has overdosed, give naloxone if you have it and call 911 right away. Store Tylenol with Codeine out of the reach of children and others.

In general, Tylenol with Codeine isn't recommended during pregnancy. It contains codeine, an opioid that can reach an unborn baby during pregnancy. If you take this medication for a long time during pregnancy, it can cause the baby to become physically dependent on opioids.

After birth, your baby can develop neonatal opioid withdrawal syndrome (NOWS). Signs can include high-pitched crying, poor feeding, shaking, irritability, unusual sleep patterns, or seizures. NOWS can be serious and needs medical care.

Tell your care team if you're pregnant or took Tylenol with Codeine during pregnancy. They can help you understand the risks and choose the safest treatment plan.

Tylenol with Codeine can interact with many medications. Starting or stopping certain medications can change how your body processes codeine and turns it into morphine. This can make Tylenol with Codeine work less well. Other interactions can raise the risk of serious opioid side effects, such as slow breathing. Examples include erythromycin (Ery-tab), rifampin, carbamazepine (Tegretol), and amiodarone (Pacerone).

Tell your care team about all the medications you take. Don't start or stop any medications without checking with them first. Your prescriber might need to adjust your medications or watch you more closely.

• Risk factors: Age 65 years and older | Taking other medications that make you less alert or slow your body down | Drinking alcohol

Tylenol with Codeine can make you very sleepy. It can also make it harder to think clearly, react quickly, and focus. Alcohol can make these effects worse. Medications that make you sleepy, like certain allergy medications, sedatives, and muscle relaxants, can also make the effects worse.

Don't drive or do anything that requires you to be alert until you know how Tylenol with Codeine affects you. Avoid drinking alcohol or taking medications that make you sleepy unless your prescriber says it's safe. Tell your care team right away if you feel very sleepy while taking Tylenol with Codeine.

• Risk factors: Drinking alcohol | Taking other medications containing acetaminophen | Taking higher than recommended dose of acetaminophen | Liver problems

Tylenol with Codeine contains acetaminophen. Taking too much acetaminophen can cause serious and sometimes life-threatening liver damage. For adults, the daily limit of acetaminophen is 4,000 mg. But your limit might be lower based on your health and your prescriber's instructions. For children, ask your child's prescriber about a safe amount.

Check with your prescriber or pharmacist before taking other medications that contain acetaminophen. Taking more than one acetaminophen product can make it easier to take too much. Also, avoid alcohol while taking Tylenol with Codeine because it can raise your risk of liver damage. Tell your prescriber if you have liver problems so they can make sure this medication is safe for you.

Call your care team right away if you notice signs of liver problems. These can include dark urine, severe tiredness, nausea or stomach pain, or yellow skin or eyes.

• Risk factors: Allergy to acetaminophen | Allergy to codeine

Tylenol with Codeine can cause a severe allergic reaction. This can include swelling of the face or anaphylaxis. Get emergency help right away if you have hives, swelling of your face, lips, or tongue, trouble breathing, or your throat feels like it's closing.

Tylenol with Codeine contains acetaminophen. Acetaminophen can cause rare but serious skin reactions. Stop taking the medication and get medical help right away if you develop a rash, blisters, skin redness, or peeling.

Tylenol with Codeine can cause low blood pressure. This includes orthostatic hypotension, which is when your blood pressure suddenly drops when you stand. This can make you feel dizzy or faint.

To avoid falling, stand up slowly while holding onto something stable. Be sure to sit back down if you feel dizzy and wait until you feel better. Talk to a healthcare professional if any dizziness or lightheadedness doesn't go away.

• Risk factors: Taking Tylenol with Codeine for longer than 1 month

Opioids like Tylenol with Codeine might lower your adrenal hormone levels. This is more likely to happen if you take it for longer than 1 month. Tell your prescriber right away if you have symptoms of low adrenal hormones. These can include nausea, vomiting, loss of appetite, tiredness, dizziness, or weakness. If this happens, your prescriber might work with you to stop Tylenol with Codeine. Then, they might treat you with a corticosteroid.

• Risk factors: History of seizure conditions

Opioids can cause people with a history of seizures to have seizures more often. Tylenol with Codeine can also raise your risk of seizures in certain situations. If you have a history of seizure, tell your prescriber if you have seizures more often while taking this medication.

Tylenol with Codeine can slow down movement in your intestines. Don't take this medication if you have a blocked intestine or certain other serious gut problems. Tell your prescriber about any digestive conditions you have before starting treatment.

• Risk factors: Stopping or lowering the dose of Tylenol with Codeine suddenly after long-term use

Taking Tylenol with Codeine for a long time can cause physical dependence. This means your body gets used to the medication. When this happens, stopping it suddenly or lowering the dose too fast can cause your pain to come back. It can also cause withdrawal symptoms, including anxiety, restlessness, irritability, cravings, a runny nose, sweating, chills, and body aches.

Take Tylenol with Codeine exactly as prescribed. Don't stop taking it or lower your dose without talking to your prescriber. If you need to stop treatment, your prescriber will slowly lower your dose to help prevent withdrawal symptoms.

Breastfeeding isn't recommended while taking Tylenol with Codeine. Your body changes some codeine into morphine. Both codeine and morphine can pass into breast milk. This can cause severe sleepiness or dangerous breathing problems in a breastfed baby. Some people turn codeine into morphine faster than others, which can raise this risk. Talk to your prescriber about safer pain treatments while breastfeeding.