butalbital / acetaminophen / caffeine / codeine

• Risk factors: Personal or family history of substance or alcohol abuse | History of mental health conditions | Taking more of Fioricet with Codeine than prescribed or using it long-term

Taking Fioricet with Codeine can lead to abuse, misuse, or addiction, even if you take it at the recommended dose. This can cause serious problems, such as overdose and death. Because of this risk, the FDA requires this medication and all other medications containing opioids, like codeine, to be under a Risk Evaluation and Mitigation Strategy (REMS) program. This means your healthcare provider or pharmacist will talk to you about the proper use, serious risks, and appropriate storage and disposal of this medication in order to keep you and your loved ones safe.

• Risk factors: Using opioids | Starting treatment with Fioricet with Codeine | Taking high doses of Fioricet with Codeine | Drinking alcohol | Taking other medications that affect your breathing | Acute or severe asthma | History of severe chronic obstructive pulmonary disease (COPD) | Older or weaker people | Accidental overdose

Fioricet with Codeine can cause serious breathing problems (respiratory depression) and lead to death if not treated right away. If you or your loved one has shortness of breath, wheezing, slowed breathing, tiredness or sleepiness during the day, anxiety, or confusion, call for emergency medical help right away. This risk can occur at any time but it's greatest during the first 1-3 days of starting Fioricet with Codeine and after increases in dosages.

Talk to your pharmacist or healthcare provider about naloxone (Narcan), which can be used in emergency situations for Fioricet with Codeine overdose. Even if you use naloxone for an overdose, you'll still have to call for emergency medical help because it's effects are temporary and only last for a few minutes.

If you have a history of alcohol use or severe lung conditions, talk to your healthcare provider before starting Fioricet with Codeine. Your provider might switch you to a non-opioid medication if necessary.

• Risk factors: Younger than 12 years of age | Using opioids after certain surgeries, like tonsil or adenoid removal | Obstructive sleep apnea (OSA) | Obesity | Severe lung conditions | Neuromuscular conditions | Taking other medications that affect your breathing | Genes that rapidly breakdown codeine

Fioricet with Codeine can cause life-threatening breathing problems (respiratory depression) and death in children, especially those younger than 12 years. Some children have genes that break down codeine faster in their body than others, so this raises their amount of exposure to the medication. The risk is even greater in children ages 12 to 18 years after certain surgeries, like tonsil or adenoid removal. If your child has obstructive sleep apnea, obesity, or severe lung conditions, discuss the risks and benefits of using Fioricet with Codeine with your child's healthcare provider. Work with your child's provider to use the lowest dose of Fioricet with Codeine for the shortest period of time to lower your child's risk of life-threatening breathing problems. If your child has shortness of breath, wheezing, slowed breathing, tiredness or sleepiness during the day, anxiety, or confusion, call for emergency medical help right away.

• Risk factors: Children | Taking more Fioricet with Codeine than prescribed

Taking even one more dose of Fioricet with Codeine than prescribed can lead to deadly overdose, especially in children. You should never take more than 6 capsules of Fioricet with Codeine per day. Symptoms of an overdose include, slowed breathing, small pupils, blue lips and fingertips, pale face, sweating, choking, or unresponsiveness. If you or anyone around you accidentally overdoses on Fioricet with Codeine, get emergency medical help or call your local poison control center at 1-800-222-1222 right away.

• Risk factors: Taking other medications that slow down brain function | Taking benzodiazepines | Drinking alcohol | Higher doses of Fioricet with Codeine | Personal or family history of substance abuse

Taking Fioricet with Codeine with alcohol or medications such as benzodiazepines for anxiety, sleep medications, muscle relaxers, and other opioids, can slow down brain activity and cause severe sleepiness, slowed breathing, coma, and death. If you take any of these medications, work with your healthcare provider to take the lowest and safest doses. Due to excessive sleepiness and dizziness, don't drive or use any heavy machinery until you know how Fioricet with Codeine affects you. Call for emergency medical help right away if you have symptoms such as sleepiness, dizziness, low heart rate, slowed breathing, muscle weakness, headache, slurred speech, blurred vision, or confusion.

• Risk factors: Long-term use of Fioricet with Codeine during pregnancy | Using opioids during labor and delivery | Exposure to breast milk containing Fioricet with Codeine

Long-term use of Fioricet with Codeine during pregnancy or during labor can cause neonatal opioid withdrawal syndrome, which is a life-threatening condition in newborn babies. It's important to recognize and treat this condition right away by watching your newborn baby for symptoms such as, irritability, overactivity, abnormal sleeping patterns, excessive or high-pitched crying, body shaking (tremor), vomiting, diarrhea, inability to gain weight, breathing problems, fever, sweating, or seizures. If you're pregnant or breastfeeding, don't use Fioricet with Codeine without discussing the risks and benefits with your healthcare provider because it could potentially harm your baby.

• Risk factors: Taking medications that interact with Fioricet with Codeine

Fioricet with Codeine interacts with many medications, causing the levels of those medications to either go up or down in your body. Using Fioricet with Codeine with antibiotics, such as erythromycin, or antifungals, such as fluconazole (Diflucan), can lead to higher levels of Fioricet with Codeine, which can cause life-threatening breathing problems. On the other hand, taking medications like rifampin (Rifadin), carbamezapine (Tegretol), and phenytoin (Dilantin) can lower Fioricet with Codeine levels and lessen the effects of the medication, which can cause opioid withdrawal symptoms, such as restlessness, sweating, chills, anxiety, nervousness, high blood pressure, or seizures. Ask your pharmacist or healthcare provider before starting or stopping any medications while taking Fioricet with Codeine for your safety.

• *Risk factors: History of liver disease | Taking high amounts of acetaminophen (Tylenol) | Drinking alcohol with acetaminophen (Tylenol) | Drinking alcohol with Fioricet with Codeine *

Fioricet with Codeine contains acetaminophen (Tylenol), and taking too much acetaminophen (Tylenol) can lead to liver failure and even death. You shouldn't take more than 4000 mg of acetaminophen (Tylenol) per day. Your risk of liver damage is higher if you drink alcohol while taking acetaminophen (Tylenol). If you have a history of liver disease or if you take high amounts of acetaminophen (Tylenol), talk to your healthcare provider to see if Fioricet with Codeine is safe for you. If you accidentally take more than 4000 mg of acetaminophen (Tylenol) in a day, call for emergency medical help even if you feel well because you could be at risk for acute liver failure.

• Risk factors: Opioid-use | Using opioids for greater than 1 month | History of low cortisol levels

Using medications containing opioids, such as Fioricet with Codeine, especially for longer than 1 month can lead to low levels of cortisol hormone (adrenal insufficiency). Cortisol helps control your mood, stress, blood pressure, and blood sugar levels. If you have symptoms such as nausea, vomiting, anorexia, tiredness, weakness, dizziness, or low blood pressure, let your healthcare provider know so that tests can be performed and you can be treated appropriately if your cortisol levels are too low. Your provider might slowly wean you off of Fioricet with Codeine or switch you to another medication if necessary.

• Risk factors: Taking blood pressure medications | History of low blood pressure | Taking certain antipsychotics | Dose adjustments to Fioricet with Codeine

Fioricet with Codeine can cause severely low blood pressure, especially upon standing after sitting or lying down for a long period of time (orthostatic hypotension). The risk is higher if you take medications for high blood pressure or if you take antipsychotics, known as phenothiazines. Be careful as you stand up after sitting for an extended period of time and make sure to sit back down if you feel faint or dizzy. The chances of low blood pressure are higher when you first start Fioricet with Codeine or with dose changes. Call for emergency medical help if you have symptoms of low blood pressure including dizziness, lightheadedness, feeling thirsty or dehydrated, not being able to concentrate, tiredness or weakness, confusion, blurred vision, cold or pale skin, or fast breathing.

• Risk factors: History of high pressure in the brain | History of brain tumors or head injury | Impaired consciousness or coma

Fioricet with Codeine can raise pressure in the brain, especially if you have a history of a brain tumor or head injury. Fioricet with Codeine affects your lungs by lowering your ability to breathe, which causes higher levels of carbon dioxide and greater pressure inside of your brain. If you feel excessive sleepiness or have slowed breathing, especially when you first start taking Fioricet with Codeine, let your healthcare provider know right away.

• Risk factors: History of stomach or intestinal blockage

You shouldn't take Fioricet with Codeine if you have a history of a stomach or intestinal blockage (paralytic ileus). Fioricet with Codeine can cause constipation which can further complicate this condition. Fioricet with Codeine can also raise amylase levels in your body, which is a protein that helps you digest food. If these levels are too high, it can lead to acute inflammation in your pancreas. If you have stomach pain or cramps, stomach swelling, nausea, vomiting, diarrhea, or fever, let your healthcare provider know right away because you might need to stop taking Fioricet with Codeine.

• Risk factors: History of seizures | Taking medications that cause seizures | Overdose with Fioricet with Codeine

The codeine in Fioricet with Codeine can raise your risk of seizures if you already have a history of seizures. If you have a seizure and it's worse or harder to control than before, let your healthcare provider know because you might have to stop taking Fioricet with Codeine and switch to another medication.

• Risk factors: Suddenly stopping Fioricet with Codeine | History of opioid dependence | Lowering the dose of Fioricet with Codeine too quickly

Stopping Fioricet with Codeine suddenly can cause serious and undesirable withdrawal symptoms, such as restlessness, watery eyes, runny nose, sleepiness, sweating, chills, muscle pain, back or joint pain, large pupils, irritability, anxiety, nervousness, weakness, stomach cramps, trouble falling asleep (insomnia), nausea, vomiting, diarrhea, high blood pressure, fast heart rate, or seizures. If you take any opioid-containing medications for a long period of time, your body gets physically dependent on the medication, so you must slowly lower (taper down) the dose to prevent withdrawal. Lowering the dose too quickly might also cause your pain to come back. Taking other types of opioids, such as nalbuphine or buprenorphine (Belbuca or Butrans), can also cause withdrawal symptoms. Let your healthcare provider know if you take any other opioids, and work closely with your provider if you want to stop taking Fioricet with Codeine.

• Risk factors: History of serious skin reactions | Allergy to acetaminophen (Tylenol)

Fioricet with Codeine contains acetaminophen (Tylenol) which can sometimes cause serious skin and allergic reactions. If you're allergic to acetaminophen, don't take Fioricet with Codeine. If you develop symptoms of an allergic reaction, such as swelling of the face, mouth, or throat, trouble breathing, itchy red rash (hives), or vomiting, stop taking Fioricet with Codeine and call for emergency medical help right away. If you develop symptoms of a skin reaction, such as a painful rash, blisters, skin itching or peeling, body aches, eye redness, cough, sore throat, or fever, stop taking Fioricet with Codeine and let your healthcare provider know because you might need to be switched to another medication.

• Risk factors: Using opioids with serotonergic medications

Fioricet with Codeine contains codeine, which can cause a rare but life-threatening condition called serotonin syndrome if combined with serotonergic medications, such as fluoxetine (Prozac) or duloxetine (Cymbalta).. Call for emergency medical help right away if you have symptoms, such as agitation, restlessness, anxiety, body shaking (tremors), shivering, stiff muscles, sweating, flushed skin, vomiting, diarrhea, high blood pressure, fast heart rate, fast breathing, or large pupils. Let your healthcare provider or pharmacist know about all of the medications you are taking or plan on taking to make sure they're safe to combine with Fioricet with Codeine.