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What are the risks and warnings for Fioricet?

Barbiturate (butalbital), acetaminophen, and caffeine analgesic combination. Used to treat tension headaches in adult and pediatric patients 12 years and older; prolonged use not advisable
Associated with concerns of abuse, medication-overuse headache, and withdrawal; boxed warning for acetaminophen hepatotoxicity risk.

Fioricet and Fiorinal are both used to treat tension headaches. Both medications contain butalbital and caffeine, but Fioricet also has acetaminophen whereas Fiorinal contains aspirin. Unlike acetaminophen, aspirin also treats inflammation and swelling. Neither medication is considered a first-choice option for treating tension headaches. Discuss both options with your healthcare provider to see which one is best for you.

Mikart Fioricet Butalbital APAP
Mikart Fioricet Butalbital APAP

Fioricet can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options

Liver damage

  • Risk factors: History of liver problems | Taking Fioricet with other acetaminophen-containing medications | Taking more than 3 to 4 grams of acetaminophen (Tylenol) in a day | Drinking alcohol

Fioricet contains acetaminophen (Tylenol), and taking too much acetaminophen raises your risk of serious liver damage. Since many over-the-counter and prescription medications contain acetaminophen (Tylenol), it’s important to be aware of how much acetaminophen (Tylenol) you’re taking throughout the day. Read package labels to make sure you aren’t using more than 3,000 mg to 4,000 mg of acetaminophen (Tylenol) per day. Your risk of liver damage is greater if you drink alcohol while taking acetaminophen.

blank iconIf you have a history of liver problems, alcohol abuse, or if you take high amounts of acetaminophen, talk to your healthcare provider before starting Fioricet. If you accidentally take more than 3,000 mg to 4,000 mg of acetaminophen in a day, call for emergency medical help even if you feel well because you could be at risk for liver damage. Some early signs of acetaminophen overdose include stomach pain, dark urine, yellowing of your skin or eyes, nausea, vomiting, sweating, weakness, and feeling tired.

Difficulty concentrating

  • Risk factors: Taking Fioricet with alcohol | Taking other medications that make you less alert | Age 65 years or older

Fioricet can affect your ability to focus, think, and react. Taking other medications that make you feel sleepy and less alert can worsen these symptoms. Avoid activities that need you to focus, like driving a car or operating machinery, until you know how this medication affects you.

Serious skin or allergic reactions

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

Fioricet contains acetaminophen (Tylenol) which can sometimes cause life-threatening skin reactions and allergic reactions. If you’re allergic to acetaminophen, don’t take Fioricet. 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 and call for emergency medical help right away. If you develop symptoms of a skin reaction, such as a reddening or peeling of the skin, painful rash, or fluid-filled blisters, stop taking Fioricet and go to the emergency room right away.

Misuse, dependence, and withdrawal

  • Risk factors: Personal or family history of substance or alcohol abuse | Taking Fioricet longer than prescribed | Taking higher doses of Fioricet than prescribed | Taking Fioricet more often than prescribed

Fioricet contains butalbital, which can be habit-forming. Misuse and abuse of Fioricet can lead to addiction, accidental overdose, and even death. It can cause physical dependence if it’s taken for a long time, meaning you might need higher doses of the medication to get the same relief. It can also cause withdrawal symptoms, like seizures, restlessness, trouble sleeping, and shakiness, if you lower your dose or stop taking the medication suddenly. To lower the risk of physical dependence, don’t take Fioricet longer than prescribed, at higher doses than prescribed, or more often than prescribed.

Call for emergency medical help if you have any symptoms of butalbital overdose, including sleepiness, trouble breathing, low blood pressure, confusion, or loss of consciousness. If you no longer want to take Fioricet, talk to your healthcare provider so they can instruct you on how to stop taking the medication safely. Speak to your healthcare provider about alternative treatments if you have concerns about taking Fioricet.