Fioricet (butalbital, acetaminophen, and caffeine)

Fioricet is a combination prescription drug that includes acetaminophen, caffeine, and butalbital. It is used to relieve tension headaches and can also be prescribed to treat mild to moderate migraine.¹

What are the ingredients in Fioricet?

The active ingredients in Fioricet are acetaminophen, caffeine, and butalbital.¹

How does Fioricet work?

The 3 active ingredients in Fioricet work together to ease migraine symptoms:¹

• Acetaminophen works to relieve pain
• Caffeine works as a stimulant to increase the acetaminophen’s effectiveness
• Butalbital is a sedative that works to decrease anxiety while causing relaxation and sleepiness

What are the possible side effects?

The most common side effects of Fioricet include:¹

• Drowsiness
• Lightheadedness
• Dizziness
• Shortness of breath
• Nausea, vomiting
• Stomach pain
• Confusion

Fioricet has a boxed warning, the strictest warning from the US Food and Drug Administration (FDA). It has this warning because it contains acetaminophen. Acetaminophen has been linked to cases of liver failure, including cases that result in liver transplant or death. Most cases are linked to taking acetaminophen doses of more than 4,000 mg per day.¹

These are not all the possible side effects of Fioricet. Talk to your doctor about what to expect when taking Fioricet. You also should call your doctor if you have any changes that concern you when taking Fioricet.

Other things to know

Fioricet can be habit-forming, so you should use extreme caution if you decide to take it. Additionally, some people who take barbituates or opioids for extended periods can experience rebound headaches, which can increase in severity. These are also known as medication overuse headaches (MOH).¹

Barbituates can cause drowsiness, and their effect can be increased by alcohol use. It is important not to drive or use heavy machinery until you know how this drug affects you.¹

There is not enough data to know if Fioricet is safe to take while pregnant or breastfeeding. Before starting treatment with Fioricet, tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. They can help you decide if Fioricet is right for you.¹

Fioricet may interact with other drugs. Before starting treatment with Fioricet, tell your doctor if you take:¹

• Monoamine oxidase (MAO) inhibitors or another antidepressant drugs
• Other narcotic analgesics,
• General anesthetics
• Tranquilizers such as chlordiazepoxide
• Sedative-hypnotics

Before beginning treatment for migraine, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Fioricet.