butalbital / aspirin / caffeine / codeine

• Risk factors: Personal or family history of substance or alcohol abuse | History of mental health conditions | Taking more Fiorinal with Codeine than prescribed | Long-term use of Fiorinal with Codeine

Taking Fiorinal 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 provide you with a medication guide and 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. It's important that you read the medication guide every time to familiarize yourself with safe use of this medication.

• Risk factors: Using opioids | First few days of treatment with Fiorinal with Codeine | Taking high doses of Fiorinal with Codeine | Drinking alcohol | Acute or severe asthma | History of severe chronic obstructive pulmonary disease (COPD) | Older or weaker people | Accidental overdose

Fiorinal with Codeine can cause serious breathing problems (respiratory depression) and lead to death if not treated right away. This risk can occur at any time but it's greatest during the first 1-3 days of starting Fiorinal with Codeine and after increases in dosages. 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.

If you have a history of alcohol use or severe lung conditions, talk to your healthcare provider before starting Fiorinal 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 | History of obstructive sleep apnea (OSA) | Obesity | Severe lung conditions | Neuromuscular conditions | Taking other medications that affect your breathing | Being born with genes that rapidly break down codeine

Fiorinal with Codeine can cause life-threatening breathing problems (respiratory depression) and death in children, especially those younger than 12 years old. Some children have genes that break down codeine faster than others, so this raises their amount of exposure to the medication. The risk is even greater in children between the ages of 12 to 18 years old, especially 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 Fiorinal with Codeine with your child's healthcare provider. Work with your child's provider to use the lowest dose of Fiorinal with Codeine for the shortest amount of time to lower your child's risk of life-threatening breathing problems. If your child complains of 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 Fiorinal with Codeine than prescribed

Taking even one more dose of Fiorinal with Codeine than prescribed can lead to deadly overdose, especially in children. You should never take more than 6 capsules of Fiorinal with Codeine per day. Talk to your pharmacist or healthcare provider about naloxone (Narcan), which can be used in emergency situations for Fiorinal 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. 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 Fiorinal with Codeine, get emergency medical help or call your local poison control center at 1-800-222-1222 right away.

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

Taking Fiorinal with Codeine with alcohol, benzodiazepines for anxiety, sleep medications, muscle relaxers, and other opioids, can slow down brain activity and lead to severe sleepiness, slowed breathing, coma, and even death. If you take any of these medications, work with your healthcare provider to take the lowest and safest dose. Due to excessive sleepiness and dizziness, don't drive or use any heavy machinery until you know how Fiorinal 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 Fiorinal with Codeine during pregnancy | Using opioids during labor and delivery | Exposure to breast milk containing Fiorinal with Codeine

Long-term use of Fiorinal 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 treat this condition right away by observing your newborn baby for 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, discuss the risks and benefits of using Fiorinal with Codeine with your healthcare provider.

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

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

Using medications containing opioids, such as Fiorinal 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 Fiorinal 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 Fiorinal with Codeine

Fiorinal with Codeine can cause severely low blood pressure, especially upon standing after sitting or lying down for long periods of time (orthostatic hypotension). The risk is greater if you take medications for high blood pressure or if you take certain 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 taking Fiorinal 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

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

• Risk factors: History of stomach or intestinal blockage | History of peptic ulcer disease | History of a serious stomach bleed | Taking aspirin or other NSAIDs | Taking high doses of aspirin | Older people | Poor health | Drinking alcohol | Taking blood-thinning medications

You shouldn't use Fiorinal with Codeine if you have a history of a stomach or intestinal blockage (paralytic ileus). Fiorinal with Codeine can cause constipation which can further complicate this condition. If you have a history of stomach ulcers (peptic ulcer disease), you shouldn't use aspirin because it can irritate your stomach lining and cause serious bleeding. If you have symptoms of a serious stomach bleed, such as black or tarry stools, bright red blood in your vomit, vomit that looks like coffee grounds, stomach cramps, dizziness, tiredness or weakness, paleness, or shortness of breath, call for emergency medical help right away.

• Risk factors: History of seizures | Taking medications that cause seizures | Fiorinal with Codeine overdose

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

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

Stopping Fiorinal with Codeine suddenly can cause serious and undesirable withdrawal symptoms. If you take any opioid-containing medications for a long amount of time, your body gets physically dependent on the medication, so you must slowly lower (taper down) the dose to prevent withdrawal symptoms. Lowering your dose too quickly can 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 have restlessness, watery eyes, runny nose, sleepiness, sweating, chills, muscle pain, back or joint pain, large pupils, irritability, anxiety, nervousness, weakness, stomach cramps, trouble falling or staying asleep (insomnia), nausea, vomiting, diarrhea, high blood pressure, fast heart rate, or seizures. Work closely with your provider if you decide to stop taking Fiorinal with Codeine.

• Risk factors: Taking aspirin or other NSAIDs during pregnancy

Fiorinal with Codeine contains aspirin, which can cause harm to your unborn baby if taken during pregnancy. Don't use any aspirin-containing products if you're 30 weeks or later in pregnancy because it can cause serious heart problems in your baby. Using aspirin at 20 weeks pregnant or later can cause kidney problems in your baby and can lower the amount of amniotic fluid in your womb, which can lead to birth defects and prevent healthy growth in your baby. If you're 20 weeks to 30 weeks pregnant and need to take aspirin, take the lowest dose for the shortest time possible. Let your healthcare provider know if you take Fiorinal with Codeine or other aspirin-containing medications for longer than 2 days so that fluid levels in your womb can be measured closely.

• Risk factors: Taking aspirin | History of blood clotting conditions | Taking aspirin before surgery | Heavy alcohol use | History of liver disease | Vitamin K deficiency

Fiorinal with Codeine contains aspirin, which stops your body from forming blood clots and raises your risk of bleeding out if you get seriously cut or hurt. This is especially serious if you have a history of blood clotting conditions (e.g., hemophilia) or liver disease because your body might already have a difficult time forming blood clots. If you take any blood-thinning medications or drink more than 3 alcoholic drinks per day, your risk of bleeding is even higher. If you're worried about your bleeding risk, ask your healthcare provider if Fiorinal with Codeine is safe for you.

• Risk factors: Giving aspirin to children or teenagers with viral infections

Fiorinal with Codeine contains aspirin, which shouldn't be used to treat viral infections, with or without fever, in children or teenagers because of the risk of Reye's syndrome. This life-threatening condition can cause swelling and damage in your child's brain and liver. Discuss other non-aspirin treatment options with your child's healthcare provider.

• Risk factors: History of serious skin reactions | Allergy to aspirin or other NSAIDs

Fiorinal with Codeine contains aspirin, which can sometimes cause serious skin and allergic reactions. If you're allergic to aspirin, don't take Fiorinal 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 Fiorinal with Codeine and call for emergency medical help right away.

If you have symptoms of a skin reaction, such as a skin rash, fever, swollen lymph nodes, or facial swelling, stop taking Fiorinal with Codeine right away. It's possible to have a fever or swollen lymph nodes without a rash, but you should still stop taking Fiorinal with Codeine and call your healthcare provider. For your safety, your provider might switch you to another medication.